Company Background
−Removed: iRhythm Technologies Inc.
−Removed: 1 is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease.
+Added: iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease.
Our principal business is the design, development, and commercialization of device-based technology to provide ambulatory cardiac monitoring services that we believe allow clinicians to diagnose certain arrhythmias quicker and with greater efficiency than other services that rely on traditional technology.
−Removed: Since first receiving clearance from the U.S.
−Removed: Food and Drug Administration (“FDA”) for our technology in 2009, we have supported physician and patient use of our technology and provided ambulatory cardiac monitoring services from our Medicare-enrolled independent diagnostic testing facilities (“IDTFs”) and with our qualified technicians.
−Removed: We have provided our Zio ambulatory cardiac monitoring services, including long-term continuous monitoring, short-term continuous monitoring, and mobile cardiac telemetry (“MCT”) monitoring services (collectively, the “Zio Services”), using our Zio Systems (as defined below).
−Removed: Each Zio System combines an FDA-cleared and CE-marked, wire-free, patch-based, 14-day wearable biosensor that continuously records electrocardiogram (“ECG”) data with a proprietary, FDA-cleared, CE-marked cloud-based data analytic software to help physicians monitor patients and diagnose arrhythmias.
−Removed: Since receiving FDA clearance, we have provided the Zio Services to over eight million patients and have collected over 2 billion hours of curated heartbeat data.
−Removed: The Company was incorporated in the state of Delaware in September 2006.
+Added: Each iRhythm product offering combines a wire-free, patch-based, 14-day wearable biosensor (United States Food and Drug Administration (“FDA”)-cleared, Conformité Européenne (“CE”)-marked and Japan Pharmaceuticals and Medical Devices Agency ("PMDA")-approved, as applicable) that continuously records electrocardiogram ("ECG") data with a proprietary cloud-based data analytic software (also FDA-cleared, CE-marked and Japan PMDA-approved, as applicable) (such biosensor and software together, an "iRhythm ACM System") to help physicians monitor patients and diagnose arrhythmias.
+Added: Since first receiving clearance from FDA for our technology in 2009, we have supported physician and patient use of this technology and provided ambulatory cardiac monitoring ("ACM") services from our Medicare-enrolled independent diagnostic testing facilities (“IDTFs”) with our qualified technicians.
+Added: We have provided ambulatory cardiac monitoring services, including long-term continuous monitoring (“LTCM”) services ("LTCM Services"), short-term continuous monitoring, and mobile cardiac telemetry (“MCT”) monitoring services ("MCT Services" and collectively, the “iRhythm Services”), using the iRhythm ACM System.
+Added: LTCM services and MCT Services are medical procedures typically ordered by physicians for patients not suspected of having life-threatening arrhythmias, but who are suspected of having infrequent, difficult-to-detect, or asymptomatic arrhythmias.
+Added: Since receiving FDA clearance, we have provided iRhythm Services via more than twelve million patient reports and have collected almost three billion hours of curated heartbeat data.
+Added: iRhythm Technologies was incorporated in the state of Delaware in September 2006 and its successor registrant iRhythm Holdings was incorporated in the state of Delaware in December 2025.
Our principal executive offices are located at 699 8th Street, Suite 600, San Francisco, California 94103, and our telephone number is (415) 632-5700.
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Cardiac Arrhythmias and the Ambulatory Cardiac Monitoring Market
−Removed: Cardiac Arrhythmias
Every year, millions of patients experience symptoms potentially associated with cardiac arrhythmias, a condition in which the electrical impulses that coordinate heartbeats do not occur properly, causing the heart to beat too quickly, too slowly, or irregularly.
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Some arrhythmias may not show symptoms, while others may lead to dizziness, shortness of breath, fainting, or chest pain.
−Removed: The most common sustained type of arrhythmia is atrial fibrillation (“Afib ” ), a condition which causes the upper chambers of the heart to beat irregularly and blood not to flow properly to the lower chambers of the heart.
−Removed: It is estimated that more than 50 million patients worldwide have Afib with at least one-third of these patients presenting as asymptomatic at the time of their diagnosis, and the condition contributes to an estimated 350,000 deaths globally each year.
−Removed: The prevalence of Afib in the United States is estimated to increase from approximately 5.2 million in 2010 to 12.1 million in 2030, and more than 450,000 hospitalizations occur each year in the United States because of Afib.
−Removed: Since Afib is more common among people over the age of 60, these numbers are expected to increase as the U.S.
+Added: The Centers for Medicare and Medicaid Services' ("CMS") Hierarchical Condition Categories (HCC 96) defines actionable arrhythmias as abnormal heart rhythms detected via monitoring that require clinical intervention, such as medication adjustment, anticoagulation, catheter ablation, or device implantation.
+Added: Cardiac arrhythmias affect approximately 1.5% to 5% of the global population, with atrial fibrillation ("Afib") being the most common.
+Added: Afib causes the upper chambers of the heart to beat irregularly and blood not to flow properly to the lower chambers of the heart.
+Added: It is estimated that more than 50 million patients worldwide have Afib with at least one-third of these patients presenting as asymptomatic at the time of their diagnosis.
+Added: This condition contributes to an estimated 350,000 deaths globally each year.
+Added: In the United States, the prevalence of Afib is estimated to be approximately 4.5% of people, or approximately 10.6 million adults diagnosed with Afib in 2019, and more than 450,000 hospitalizations occur each year in the United States because of Afib.
+Added: Because Afib is more common among people over the age of 60, these numbers are expected to increase as the U.S.
population ages.
−Removed: In Europe, the prevalence of arrhythmias is also expected to continue to rise with atrial fibrillation affecting an estimated 7.6 million people over 65 in the EU in 2016 and projections indicating a surge to 9.5% of individuals over 65 by 2060.
−Removed: 1 As used throughout the text of Items 1 to 7, on Form 10-K, the term “iRhythm,”, “the Company,” “we” or “us,” refers to iRhythm Technologies, Inc., a Delaware corporation, or iRhythm Technologies Inc.
−Removed: and its consolidated subsidiaries, as the context requires.
+Added: In Europe, the prevalence of arrhythmias is also expected to continue to rise with Afib affecting approximately 12.9 million people in the EU in 2021, and projections indicating the number could double by 2050–2060.
Atrial Fibrillation and Stroke
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While individuals with Afib are approximately five times more likely to suffer a stroke, the American Stroke Association (“ASA”) estimated in 2022 that up to 80% of second clot-related strokes may be preventable.
−Removed: According to the AHA, stroke costs the United States an estimated $34.5 billion each year in healthcare costs and lost productivity and is a leading cause of serious long-term disability.
+Added: According to the American Heart Association ("AHA"), stroke costs the United States an estimated $34.5 billion each year in healthcare costs and lost productivity and is a leading cause of serious long-term disability.
Between 15% and 20% of people who have strokes also have Afib.
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Afib burden, or the amount of time a patient spends in Afib during the period of time the patient is wearing a heart monitor, has been identified in the clinical community as a clinically relevant measure for helping to determine appropriate and effective therapeutic interventions to manage patients with Afib and for assessing stroke risk.
−Removed: We believe the calculated Afib burden is only as good as the data available for analysis during the monitoring period.
−Removed: Since the most common type of Afib occurs intermittently, we believe that long-term continuous monitoring with patch-based technology, such as with the Zio patch technology that is part of our Zio Systems, can more accurately measure Afib burden as it captures the patient’s heartbeat data is captured continuously through the wear period.
+Added: We believe the calculated Afib burden is only as good as the data available for analysis d uring the monitoring period.
+Added: Since the most common type of Afib occurs intermittently, we believe that long-term continuous monitoring with patch-based technology, such as with our monitor technology that is part of our iRhythm ACM Systems, can more accurately measure Afib burden as it captures the patient’s heartbeat data is captured continuo usly through the wear period.
Ambulatory Cardiac Monitoring Overview
−Removed: The ambulatory cardiac monitoring (“ACM”) market is well-established in the United States with an estimated 6.5 million diagnostic tests performed annually with meaningful expansion anticipated in the coming years due to an aging population, a rising number of heart-related disorders globally, and broader acceptance of innovative medical technologies.
+Added: The ACM market is well-established in the United States with an estimated 6.9 million diagnostic tests performed in 2025 with meaningful expansion anticipated in the coming years due to an aging population, a rising number of heart-related disorders globally, and broader acceptance of innovative medical technologies.
Traditional ambulatory cardiac monitoring devices used by physicians for diagnosing patients with suspected arrhythmias – such as traditional, 24-to-48-hour Holter and cardiac event monitors – are constrained by short-term monitoring times, non-continuous data collection and reporting, cumbersome equipment, and/or lower patient compliance.
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For longer term (i.e., up to 30 days) event driven monitoring, physicians may prescribe ambulatory cardiac event monitoring services, including MCT services, which record ECG data upon auto-detection (i.e., asymptomatic events) and/or patient activation (i.e., symptomatic events) and may transmit such data wirelessly to a monitoring center like an IDTF.
−Removed: Physicians may also prescribe implantable loop recorders, which are implanted underneath the patient’s skin in a minimally invasive, hospital-based procedure and record ECG data similar to cardiac event monitors but are intended for monitoring up to 3 years.
+Added: Physicians may also prescribe implantable loop
+Added: recorders, which are implanted underneath the patient’s skin in a minimally invasive, hospital-based procedure and record ECG data similar to cardiac event monitors but are intended for monitoring up to 3 years.
If the diagnosis is not definitive following the first monitoring period, physicians may prescribe a repeat traditional, 24-to-48-hour Holter monitoring test or, alternatively, event monitoring services, MCT, or implantable loop recorders.
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Some physicians own their own ambulatory cardiac monitoring devices and provide ambulatory monitoring services directly to their patients, while others outsource these services to third-party providers, including IDTFs.
+Added: Opportunities in Monitoring for Undiagnosed Arrhythmias
+Added: A substantial portion of patients with clinically actionable arrhythmias, including atrial fibrillation, remain undiagnosed due to the intermittent and often asymptomatic nature of these conditions.
+Added: We estimate that in 2025 approximately 27 million individuals in the United States may be at elevated risk for undiagnosed arrhythmias.
+Added: Undiagnosed and untreated arrhythmias may result in significantly higher healthcare resource utilization and cost, potentially avoidable serious medical events, and poorer outcomes.
+Added: Real-world evidence across Medicare and commercially-insured populations indicates that patients with arrhythmias experience higher rates of emergency department visits, inpatient hospitalizations, readmissions, and overall healthcare expenditures compared to similar patients without arrhythmias, particularly among those with comorbid conditions such as type 2 diabetes ("T2D"), chronic obstructive pulmonary disease ("COPD"), chronic kidney disease, and others.
+Added: Clinical studies and guideline updates support the use of extended ambulatory monitoring to improve detection of arrhythmias compared to short-duration monitoring modalities.
+Added: Evidence from randomized trials and real-world claims analyses suggests that earlier identification of arrhythmias using long-term continuous monitoring is associated with fewer acute care events and a shift toward more appropriate outpatient management over time.
+Added: We believe iRhythm is uniquely positioned to address this opportunity through our scalable service model, long-term continuous monitoring capabilities, extensive clinical evidence base, and proprietary artificial intelligence.
+Added: Our services are increasingly utilized by innovative, value-based and risk-bearing care organizations seeking to proactively identify arrhythmias within defined patient populations, particularly those with elevated clinical risk.
+Added: Furthermore, peer-reviewed real-world evidence demonstrates that proactive ACM generates meaningful healthcare cost savings, particularly in high-risk populations.
+Added: Studies published in 2024 and 2025 examining patients with T2D and COPD found that patients who developed arrhythmias incurred 1.6–1.8x higher annual costs of care — up to $46,484 versus $30,802 for patients with both T2D and COPD — driven by hospitalization and emergency department visit rates more than two times higher than matched controls.
+Added: Importantly, T2D patients monitored with ambulatory ECG devices experienced 70% fewer hospitalizations, 44% fewer 30-day readmissions, and nearly 50% fewer emergency department visits compared to unmonitored patients, while monitored COPD patients with arrhythmia saw approximately 30% lower hospitalization incidence and related costs, demonstrating that earlier detection meaningfully bends the cost curve in these patient cohorts.
+Added: However, not all monitoring modalities deliver equivalent value.
+Added: The Cardiac Ambulatory Monitor EvaLuation of Outcomes and Time to Events (“CAMELOT”) study of 287,789 Medicare beneficiaries and the Assessment of Variation in AmbuLatory Cardiac MONitoring (“AVALON”) study of 428,707 commercially insured patients found that LTCM with Zio achieved the highest diagnostic yield, the shortest time to diagnosis, and the lowest total healthcare expenditures, while Holter monitors were 50% less likely, event monitors 42% less likely to detect a specified arrhythmia, and LTCM competing devices 1.4x to 4.3x more likely to require costly retesting.
+Added: CAMELOT further demonstrated that long-term continuous monitoring was associated with 180 fewer emergency department visits, 80 fewer inpatient hospitalizations, and 920 fewer outpatient visits per 1,000 patients compared to Holter.
+Added: As the market leader delivering more than 70% of LTCM services in the United States as of 2025, we believe our Zio platform is uniquely positioned to deliver this value as payers increasingly prioritize diagnostic accuracy and first-test resolution to reduce total cost of care.
+Added: Over time, we intend to support targeted, evidence-based monitoring strategies that leverage data-driven risk stratification and integrate seamlessly into existing clinical workflows.
+Added: These efforts are designed to expand access to care, improve clinical outcomes, and inform future growth opportunities, while remaining aligned with our disciplined approach to investment, commercialization, and regulatory compliance.
Our Products and Services
−Removed: Zio Systems and Zio Services
−Removed: The Zio Systems and Zio Services deliver a patient-friendly design that enables between 98%-99% patient compliance with minimal ECG data noise or artifact, thereby potentially delivering superior clinical accuracy to physicians diagnosing arrhythmias and reducing the cost of care for healthcare systems by avoiding costly downstream adverse events.
−Removed: We have developed a proprietary system that combines an FDA-cleared and CE-marked wire-free, patch-based, 14-day wearable biosensor that continuously records ECG data, with a proprietary FDA-cleared and CE-marked cloud-based data analytic platform to help physicians monitor patients and diagnose arrhythmias (collectively, the “Zio System”).
−Removed: We currently offer three Zio System options — the Zio Monitor System, the Zio XT System, and the Zio AT System.
−Removed: Zio ECG monitors are designed to provide high-quality, accurate data with patient compliance for up to 14 days of wear time.
+Added: Our iRhythm ACM Systems deliver a proprietary, patient-friendly design that enables between 98%-99% patient compliance with minimal ECG data noise or artifact, and the iRhythm Services thereby potentially deliver high clinical accuracy to enable physicians diagnosing arrhyt hmias and reducing the cost of care for healthcare systems by avoiding costly downstream adverse events.
+Added: We currently offer three iRhythm ACM System options — the Zio monitor System, the Zio XT System, and the Zio AT System.
+Added: ACM monitors are designed to provide high-quality, accurate data with patient compliance for up to 14 days of wear time.
Data on file.
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iRhythm Technologies.
−Removed: Data on file.
−Removed: iRhythm Technologies;
*Continuous, uninterrupted refers to the recording of ECG data.
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Refer to the Zio AT labeling and Clinical Reference Manual for full contraindications.
−Removed: The Zio Service Monitoring Solutions
−Removed: The Zio Monitor System is a prescription-only, remote ECG monitoring system that consists of a patch ECG monitor (the “Zio Monitor patch”) that records the electric signal from the heart continuously for up to 14 days and the Zio ECG Utilization Software (“ZEUS”) System, which supports the capture and analysis of ECG data recorded by the Zio Monitor patch at the end of the wear period, including specific arrhythmia events detected by the ZEUS System.
−Removed: The Zio XT System is the previous generation of the Zio Monitor System and is a prescription-only, remote ECG monitoring system that consists of a patch ECG monitor (the “Zio XT patch”) that records the electric signal from the heart continuously for up to 14 days and the ZEUS System, which supports the capture and analysis of ECG data recorded by the Zio XT patch at the end of the wear period, including specific arrhythmia events detected by the ZEUS System.
−Removed: The Zio Monitor patch is 72% smaller, 62% lighter, and 23% thinner than our Zio XT patch, attributes which have contributed to a positive impact on patient experience, including improved patient satisfaction, and associated improvement in device wear times.
−Removed: Furthermore, the Zio Monitor patch incorporates a breathable adhesive construct, which enhances the patient experience by removing moisture otherwise captured next to the patient’s skin, as well as Bluetooth communication capabilities and improved processing efficiency.
−Removed: Zio Monitor Patch and Zio XT Patch
−Removed: The Zio AT System is a prescription-only, remote ECG monitoring system that similarly consists of a patch ECG monitor (the “Zio AT patch”) that records the electric signal from the heart continuously for up to 14 days and the ZEUS System, but which also incorporates the Zio AT wireless gateway that provides connectivity between the Zio AT patch and the ZEUS System during the patient wear period.
−Removed: The wireless gateway, slightly larger than a smart phone, is provided to the patient at the time of Zio AT patch application and collects and transmits data from the Zio AT patch to the cloud via a long-term evolution (“LTE”) cellular protocol.
−Removed: Zio AT Patch and Wireless Gateway
−Removed: We support physician and patient use of our Zio Systems through our Medicare-enrolled IDTF and qualified technicians, who perform the technical monitoring services associated with a physician’s order for long-term continuous monitoring or MCT monitoring services.
+Added: The Zio Monitoring Solutions
+Added: The Zio monitor System is a prescription-only, remote ECG monitoring system that consists of a patch ECG monitor (“Zio monitor”) that records the electric signal from the heart continuously for up to 14 days and the Zio ECG Utilization Software (“ZEUS”), which supports the capture and analysis of ECG data recorded by the Zio monitor at the end of the wear period, including specific arrhythmia events detected by ZEUS.
+Added: The Zio XT System is the previous generation of the Zio monitor System and is a prescription-only, remote ECG monitoring system that consists of a patch ECG monitor (“Zio XT”) that records the electric signal from the heart continuously for up to 14 days and ZEUS, which supports the capture and analysis of ECG data recorded by the Zio XT at the end of the wear period, including specific arrhythmia events detected by ZEUS.
+Added: Zio monitor is 72% smaller, 62% lighter, and 23% thinner than Zio XT, attributes which have contributed to a positive impact on patient experience, including improved patient satisfaction, and associated improvement in device wear times.
+Added: Furthermore, Zio monitor incorporates a breathable adhesive construct, which enhances the patient experience by removing moisture otherwise captured next to the patient’s skin, as well as Bluetooth communication capabilities and improved processing efficiency.
+Added: Zio monitor Device and Zio XT Device
+Added: The Zio AT System is a prescription-only, remote ECG monitoring system that similarly consists of a patch-based ECG monitor (“Zio AT”) that records the electric signal from the heart continuously for up to 14 days and ZEUS, but which also incorporates the Zio AT wireless gateway that provides connectivity between Zio AT and ZEUS during the patient wear period.
+Added: The wireless gateway, slightly larger than a smart phone, is provided to the patient at the time of Zio AT application on the patient and collects and transmits data from the Zio AT to the cloud via a long-term evolution (“LTE”) cellular protocol.
+Added: Zio AT and Wireless Gateway
+Added: We support physician and patient use of our iRhythm ACM Systems through our Medicare-enrolled IDTF and qualified technicians, who perform the technical monitoring services associated with a physician’s order for long-term continuous monitoring or MCT monitoring services.
Long-term continuous monitoring services (the “Zio LTCM Service”) and MCT services (the “Zio MCT Service”) are diagnostic medical procedures typically ordered by physicians for patients not suspected of having life-threatening arrhythmias, but who are suspected of having infrequent, difficult-to-detect, or asymptomatic arrhythmias.
−Removed: When physicians order long-term continuous monitoring services with our Zio System, our biosensor technology collects an uninterrupted, long-term continuous recording of ECG data for up to 14 days and delivers a comprehensive end-of-wear report, which includes specific arrhythmia events detected by the ZEUS algorithm upon return of the Zio Monitor patch or Zio XT patch (and with the Zio AT patch, each, a “Zio patch”) and analysis of the stored data by qualified technicians.
+Added: When physicians order long-term continuous monitoring services with our iRhythm ACM System, our biosensor technology collects an uninterrupted, long-term continuous recording of ECG data for up to 14 days and delivers a comprehensive end-of-wear report, which includes specific arrhythmia events detected by the ZEUS algorithm upon return of Zio monitor or Zio XT (and with Zio AT, each, a “Zio patch”) and analysis of the stored data by qualified technicians.
A Zio patch typically collects approximately 1.5 million heartbeats of data for each patient during a single wear period of up to 14 consecutive days.
−Removed: After we receive the Zio patch at our IDTF, the ECG data is uploaded to our secure cloud and preliminary findings are generated by our proprietary FDA-cleared deep learning algorithms.
+Added: After we receive a Zio monitor device at our IDTF, the ECG data is uploaded to our secure cloud and preliminary findings are generated by our proprietary FDA-cleared deep learning algorithms.
Each report is then validated by qualified technicians and sent to the patient’s prescribing physician who may access the Zio report on our proprietary, web-based portal, referred to as ZioSuite, and also through our Electronic Health Record (“EHR”) connections or ZioSuite mobile apps.
−Removed: Our technicians also notify physicians of potential urgent arrhythmias according to the ordering physician’s specified notification criteria.
+Added: Our technicians also notify physicians of certain potentially clinically actionable arrhythmias according to the ordering physician’s specified notification criteria.
ZioSuite Web Portal Via Desktop or Mobile Application
−Removed: For the Zio MCT Services, the Zio AT patch and wireless gateway also offer the additional capability of providing actionable transmissions during the wear period to assist physicians in diagnosing and treating patients in situations where their physician has determined that there is a medical need to receive more timely, clinically actionable information.
−Removed: For the MCT services, physicians will receive daily reports, routine reports, and notifications from qualified technicians if there are significant events that meet predetermined and physician-specified notification criteria.
+Added: For the Zio MCT Services, Zio AT and its wireless gateway also offer the additional capability of providing actionable transmissions during the wear period to assist physicians in diagnosing and treating patients in situations where their physician has determined that there is a medical need to receive more clinically actionable information during wear.
+Added: For the Zio MCT Services, physicians will receive daily reports, routine reports, and notifications from qualified technicians if there are clinically actionable events that meet predetermined and physician-specified notification criteria.
While wearing a Zio patch, patients can mark when symptoms occur by pressing a trigger button on the device and separately recording contextual data like activities and circumstances in a written symptom diary or digitally via the myZio application.
This allows physicians to match symptoms and activity with ECG-based findings.
−Removed: The Zio patches are not available for sale outside of use with our Zio Services.
−Removed: The Zio patches include the following features:
+Added: The Zio patch monitors are not available for sale outside of use with our iRhythm Services.
+Added: The Zio patch monitors include the following features:
• patented clear, flexible, lightweight, wire-free design;
• unobtrusive and inconspicuous profile;
−Removed: • proprietary adhesive backing designed to keep the Zio patch securely in place for the duration of the prescribed wear period;
+Added: • proprietary adhesive backing designed to keep the patch-based monitor device securely in place for the duration of the prescribed wear period;
• water-resistant functionality, allowing patients to shower, sleep, and perform normal daily activities, including moderate exercise;
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• large symptom button, or patient trigger, that is easy to find and press;
−Removed: • indicated single application wear period of up to 14 days (for longer prescribed wear periods for MCT services, additional Zio AT patches and gateways can be provided);
+Added: • indicated single application wear period of up to 14 days (for longer prescribed wear periods for MCT services, additional Zio ATs and gateways can be provided);
• sufficient battery power for the entire wear period, without the need to recharge or replace batteries.
−Removed: The Zio Platform for Clinical-grade Wearables
−Removed: We believe a clinical need and an opportunity exists to expand our Zio platform into clinical-grade wearables to detect and characterize arrhythmias while integrating with clinicians’ workflows.
−Removed: As part of this expansion strategy, we partnered with Verily Life Sciences LLC, an Alphabet Company (“VLS”) and Verity Ireland Limited (“VIL,” and together with VLS, “Verily”) to develop their Verily Study Watch wearable device into a clinical platform.
−Removed: We developed the Zio ® Watch (Study Watch with Irregular Pulse Monitor) with our clinically integrated ZEUS System, a solution that is intended to be integrated into clinical care delivery and to assist healthcare providers in identifying and monitoring Afib.
−Removed: We have what we believe to be the world’s largest repository of labelled ECG data, which we leveraged to develop our proprietary photoplethysmography (“PPG”) algorithms utilized in both the Zio Watch and the ZEUS System.
−Removed: In July 2022, we received FDA clearance on the clinically integrated ZEUS System, the AI algorithm and solution component of the Zio Watch.
−Removed: The Zio Watch has not been commercially launched.
−Removed: We are evaluating potential opportunities to leverage our PPG algorithms and ZEUS System with other PPG-based wearables, and we intend to further pursue development opportunities on a wearable platform in the future.
+Added: Clinical-grade Wearables
+Added: We believe that there is a clinical need and an opportunity to expand our products and services with clinical-grade wearables to detect and characterize arrhythmias while integrating with clinicians’ workflows.
+Added: As part of this expansion strategy, we have developed proprietary photoplethysmography ("PPG") algorithms designed to be integrated into a wearable device and utilized with our clinically integrated ZEUS System, a solution that is intended to be incorporated into clinical care delivery and assist healthcare providers in identifying and monitoring Afib.
+Added: are evaluating potential opportunities to leverage our PPG algorithms and ZEUS System with PPG-based wearables, and we intend to further pursue development opportunities on a wearable platform in the future.
The iRhythm Difference
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Long-term, continuous monitoring maximizes diagnostic yield 1
−Removed: 1, Turakhia et al.
+Added: 1, Turakhia MP, Hoang DD, Zimetbaum P, et al.
Diagnostic utility of a novel leadless arrhythmia monitoring device.
−Removed: The American Journal of Cardiology , 2013.
−Removed: Taken together, we believe that these elements are differentiators for the Zio Systems in the diagnosis and treatment of cardiac arrhythmias and can lead to improved clinical outcomes, enhanced patient experience, high physician and healthcare staff satisfaction, and reduced cost of care to healthcare systems.
−Removed: This was demonstrated by the results from the Cardiac Ambulatory Monitor EvaLuation of Outcomes and Time to Events (“CAMELOT”) study that were published in the American Heart Journal in December 2023.
−Removed: The largest ever real-world evidence study of ambulatory cardiac monitoring, it revealed that the Zio LTCM Service using the Zio XT System was independently associated with the highest yield of clinical arrhythmia encounter diagnosis, lowest likelihood of retest, and the lowest incremental healthcare resource utilization of all strategies examined.
−Removed: Results of the CAMELOT study 1-4
+Added: Am J Cardiol.
+Added: 2013;112(4):520-524.
+Added: doi:10.1016/j.amjcard.2013.04.017
+Added: Taken together, we believe that these elements are differentiators for iRhythm's Services in the diagnosis and treatment of cardiac arrhythmias and can lead to improved clinical outcomes, enhanced patient experience, high physician and healthcare staff satisfaction, and reduced cost of care to healthcare systems.
+Added: This was demonstrated by the results from the CAMELOT and AVALON studies which evaluated over 700,000 diagnostic-naive patients across Medicare fee-for-service ("FFS") and commercial populations through two landmark real-world studies.
+Added: The CAMELOT and AVALON studies offered robust insight into the iRhythm ACM Systems' effectiveness in detecting meaningful arrhythmias in first-time monitoring patients, demonstrating that our LTCM Service had the highest arrhythmia diagnostic yield, lower likelihood of repeat testing, reduced inpatient hospitalizations, fewer emergency department visits, and overall lower healthcare resource utilization compared to all other monitoring services.
Reynolds et al.
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2024;269:25-34.
−Removed: A specified arrhythmia refers to an arrhythmia encounter diagnosis as per Hierarchical Condition Categories (HCC) 96.
−Removed: Based on previous generation Zio XT device data.
−Removed: Zio Monitor utilizes the same operating principles and ECG algorithm.
−Removed: Additional data on file.
+Added: 10.1016/j.ahj.2023.12.002 2.
+Added: Assessment of variation in ambulatory cardiac monitoring among commercially insured patients.
+Added: Am J Manag Care.
+Added: Published online August 13, 2025.
+Added: doi:10.37765/ajmc.2026.89782 3.
Zio LTCM service refers to Zio XT and Zio monitor service.
−Removed: Opportunities in Monitoring for Undiagnosed Arrhythmias
−Removed: Currently, the Zio Services are generally ordered by physicians for patients that are experiencing symptoms, with limited provision of these services for the estimated one-third of the U.S.
−Removed: population that may be experiencing undiagnosed arrhythmias, including Afib.
−Removed: Because Afib is associated with increased risk of clinical outcomes such as stroke and heart failure, we see a future opportunity in supporting physicians in the proactive assessment of the approximately 12 million patients who are at high risk of undiagnosed Afib or other clinically actionable arrhythmias to identify those with the illness, enabling initiation of appropriate therapies which may reduce risks.
−Removed: To that end, iRhythm established the “Know Your Rhythm” program with the goal of enabling population health management strategies to identify undiagnosed arrhythmias in a defined patient population by using data-driven risk stratification, early disease identification, and targeted interventions.
−Removed: What was initially conceived as our ‘Know Your Rhythm’ program for payor channels has been instead organically adopted by innovative, value-based care organizations to encapsulate proactive monitoring strategies.
−Removed: Early success of the Zio Services within this paradigm has been the culmination of several factors iRhythm has been driving over the past few years.
−Removed: The known increases in health care utilization and costs have been met with a focus on serving patients in lower cost settings of care.
−Removed: The ease of use for physicians and patients alike of our Zio Monitor System, together with iRhythm’s clinical evidence demonstrate the Zio Services' ability to identify undiagnosed arrhythmias and the cost-effectiveness of a proactive arrhythmia monitoring approach.
−Removed: To this end, we intend to utilize a precision artificial intelligence approach to better apply risk factor-based monitoring for atrial fibrillation and other arrhythmias in targeted patient populations — many that would not be identified with conventional criteria.
−Removed: In 2024, the European Society for Cardiology updated their practice guidelines for management of Afib to include recommended screening in all patients 75 years and older and for those 65 and older with additional risk factors.
−Removed: We have participated in multiple clinical studies, including SCREEN-AF, GUARD-AF, and mHealth Screening to Prevent Strokes ("mSToPS") which have demonstrated significant increases in Afib detection using Zio LTCM Services versus routine clinical care.
−Removed: During a three-year follow-up period in the mSToPS study, Afib screening with the Zio LTCM Service was associated with a reduction in the rate of the combined endpoint of stroke, death, systemic emboli, and myocardial infarction as compared to an observational cohort that did not participate in active screening.
−Removed: In patients who have suffered an ischemic stroke, identification of the underlying cause is important in prevention of recurring strokes and to improve patient outcomes.
−Removed: The 2024 American College of Cardiology expert consensus decision statement on arrhythmia monitoring after stroke now recommends ambulatory cardiac monitoring of 14 or more days as the primary modality for use in detection of Afib in cases of stroke of unknown origin.
−Removed: The Zio LTCM Service was shown to be superior to Holter monitoring for detection of Afib in post-stroke patients as part of the Early Prolonged Ambulatory Cardiac Monitoring in StrokeTrial.
−Removed: Utility of Zio Long-term Continuous Monitoring in Ventricular Rhythms
−Removed: Recently published literature has also demonstrated the value of 14-day long-term continuous monitoring in assessment of ventricular rhythms, including ventricular tachycardia and premature ventricular contractions (“PVC”).
−Removed: Hypertrophic cardiomyopathy (“HCM”) is among the most common genetic heart diseases and patients are at increased risk for ventricular tachycardia and sudden cardiac death.
−Removed: A 2024 study conducted by Rowin et al.
−Removed: assessed the incidence of ventricular tachycardia in 236 HCM patients and concluded that 14-day continuous monitoring with Zio LTCM Services identified three times as many patients with high-risk episodes as compared to Holter monitoring over 48 hours, the standard duration for Holter monitoring.
−Removed: Additionally, a 2024 study conducted by Krumerman et al.
−Removed: assessed 106,705 patients with elevated PVC burden and demonstrated reduced error in determining the burden of PVC with 14-day continuous monitoring as compared to short-term monitoring durations.
−Removed: This enabled improved classification of patients with respect to burden level, which is associated with increased risk for reduced ejection fraction and heart failure.
−Removed: We believe that these studies together illustrate that 14-day continuous monitoring with the Zio Services may improve sensitivity for risk identification in ventricular rhythms and provides additional data valuable in clinical decision-making, such as determining the need for the implantable cardioverter defibrillator implant to reduce risk of sudden cardiac death in HCM patients, or the use of ablation procedures to reduce heart failure risks in patients with elevated PVC burden.
+Added: The Zio service facilitates a diagnosis as determined by a physician.
+Added: In AVALON, arrhythmias were defined by a panel of clinical experts and study investigators.
+Added: In CAMELOT, A specified arrhythmia refers to an arrhythmia encounter diagnosis as per Hierarchical Condition Categories (HCC) 96.
Our mission is to boldly innovate to create trusted solutions that detect, predict, and prevent disease.
−Removed: The key elements of our strategy include:
−Removed: • Further penetrating and expanding the U.S.
−Removed: ambulatory cardiac monitoring market .
−Removed: Our goal is to be the leading provider of ambulatory cardiac monitoring for patients at risk for arrhythmias.
−Removed: We intend to expand our market penetration by targeting the large existing ambulatory cardiac monitoring market in the United States and driving broader awareness of its advantages.
−Removed: We plan to leverage our portfolio of products, including the Zio Monitor System and Zio AT System, and position Zio Services as providing certainty in a single test due to high patient compliance and superior quality of uninterrupted data.
−Removed: The Zio Monitor System, which provides continuous long-term ECG monitoring, is designed to be appropriate for the majority of patients that require ambulatory cardiac monitoring while the Zio AT System, which includes near real-time monitoring, is intended for more acute patients that require timely notification.
−Removed: We estimate our current market penetration in the United States to be over 30%.
−Removed: Marketing and education throughout the medical community are key to bringing awareness and communicating the strong clinical evidence backing Zio Services.
−Removed: In addition, we expect to continue developing and publishing clinical evidence to demonstrate the potential advantages of Zio Services relative to legacy and competitive monitoring technologies.
−Removed: Within existing accounts, we expect to continue to introduce our Zio Services beyond cardiology and electrophysiology into other departments, including primary care, neurology, and emergency room.
−Removed: To enable this broader adoption within a hospital system, we have successfully interfaced the Zio ordering and report posting processes into a number of large health systems’ electronic health record (“EHR”) systems.
−Removed: This seamless integration of Zio workflow processes has proven to be a key factor in spurring growth within existing and new accounts and is an important part of our ongoing market penetration strategy.
−Removed: Furthermore, we believe there is potential to increase the core symptomatic total addressable market by moving further upstream in the care pathway to the primary care physician call point.
−Removed: We estimate that 15 million patients in the United States visit a primary care physician annually with palpitations due to suspected cardiac disease.
−Removed: In addition to approaching primary care physicians directly, we also are able to leverage virtual cardiology providers as key partners to deliver clinical decisions.
−Removed: By educating primary care physicians on the benefits of Zio Services for this patient population, we believe we can expand the market and reach more patients that are candidates for ambulatory cardiac monitoring.
+Added: We execute this mission through a focused strategy that builds on our leadership in ambulatory cardiac monitoring, expands access to care, and selectively extends our platform into adjacent clinical opportunities, while maintaining operational discipline and scalability.
+Added: • Leading and Expanding Within the Core Ambulatory Cardiac Monitoring Market.
+Added: iRhythm is a leading provider of ambulatory cardiac monitoring services in the United States, with approximately 40% penetration of the core ambulatory cardiac monitoring market.
+Added: Our strategy is anchored in our products' continued leadership in long-term continuous monitoring, which we believe offers high diagnostic yield, clinical accuracy, and efficiency compared to short-duration or event-based monitoring modalities.
+Added: We intend to further penetrate the core market by expanding utilization within cardiology and electrophysiology practices while increasing adoption across additional clinical specialties and settings, including primary care.
+Added: We believe our differentiated combination of patient-friendly, long-term wearable biosensors, proprietary FDA-cleared artificial intelligence algorithms, and integrated digital workflows enables physicians to obtain diagnostic certainty in a single test, improving patient care while reducing downstream healthcare utilization.
+Added: Marketing, physician education, and continued publication of peer-reviewed clinical evidence remain central to this strategy.
+Added: We also continue to expand EHR integrations to streamline ordering, reporting, and clinical decision-making, which we believe supports sustained growth within existing and new accounts.
+Added: • Unlocking Market Expansion Through Access, Evidence, and Artificial Intelligence.
+Added: We believe the ambulatory cardiac monitoring market extends well beyond traditionally symptomatic patients and that significant opportunity exists to expand access earlier in the care pathway.
+Added: Capacity constraints in cardiology, coupled with a growing prevalence of arrhythmias and an aging population, are driving increased adoption of monitoring solutions in primary care and integrated delivery networks.
+Added: Our strategy emphasizes expanding adoption in primary care and other non-cardiology settings by positioning our services as a rule-in and rule-out diagnostic tool that enables efficient triage and referral.
+Added: We believe this approach improves access to care, reduces unnecessary specialist visits, and supports more timely diagnosis and treatment.
+Added: In parallel, we are pursuing proactive monitoring strategies focused on patients at risk for undiagnosed arrhythmias.
+Added: With an estimated 27 million individuals as of 2025 in the United States potentially at elevated risk for undiagnosed arrhythmias, we believe iRhythm is uniquely positioned to support population health initiatives through scalable, evidence-based monitoring programs.
+Added: Our extensive repository of curated ECG data, combined with external data sources and advanced artificial intelligence, underpins our efforts to improve identification, prediction, and stratification of arrhythmia risk.
+Added: We believe these capabilities differentiate our platform and enable more targeted, efficient monitoring strategies over time.
• Pursuing international expansion opportunities.
−Removed: While our initial commercial focus is the U.S.
−Removed: market, we have initiated efforts that will allow for future expansion into international geographies.
−Removed: We have a presence in the UK with efforts underway to pursue national reimbursement.
−Removed: In September 2020, we were named a winner of the Artificial Intelligence in Health and Care Award run by the Accelerated Access Collaborate as part of the National Health Service (“NHS”) AI Lab.
−Removed: This funding brought Zio Services to selected NHS sites over a three-year program measuring clinical, pathway, and economic outcomes.
−Removed: We also received positive guidance from the National Institute for Health and Care Excellence (“NICE”) in December 2020 for the adoption of the Zio XT Service which may facilitate future support of Zio Services through the MedTech Funding Mandate.
−Removed: We are also conducting diligence and prioritizing other geographies based on market size, regulatory pathway, and reimbursement opportunity.
−Removed: We initiated commercial launch of the Zio Monitor System and Zio Services in Austria, the Netherlands, Spain, and Switzerland in the third quarter of 2024 and were granted regulatory approval in Japan in September 2024.
−Removed: We estimate the total addressable market in our initial selected countries of the UK, Japan, and prioritized European countries to be at least 5 million existing ambulatory monitoring tests annually.
−Removed: • Exploring adjacent market opportunities.
−Removed: We intend to continue assessing the potential pathways for expanding indications and clinical use cases for our Zio Services and developing new systems for patient populations with unmet needs.
−Removed: Leading with clinical and economical evidence, we are pursuing commercialization opportunities for proactive monitoring strategies that are focused on patients at risk for undiagnosed arrhythmias.
−Removed: With at least 12 million individuals in the United States estimated to be at risk for undiagnosed cardiac arrhythmias, we believe this could be a significant market opportunity for which we believe Zio Services are uniquely positioned to succeed.
−Removed: Initial efforts to proactively monitor this population with the Zio Monitor System were initiated in 2024 and will be continued into 2025.
−Removed: In addition, we are actively exploring opportunities in adjacent markets beyond ambulatory cardiac monitoring.
−Removed: We have research and development efforts focused on exploring the use of our Zio Services or other new systems and services for the following patient populations:
+Added: While the United States remains our primary market, we are selectively expanding internationally in geographies with established regulatory pathways, reimbursement potential, and unmet clinical need.
+Added: Our international strategy prioritizes disciplined investment, local clinical evidence generation, and reimbursement progression.
+Added: We have established a commercial presence in the United Kingdom, selected European countries, and Japan, which collectively represent an estimated three million existing ambulatory cardiac monitoring services performed annually.
+Added: We intend to scale these markets deliberately over the medium to long term, focusing on embedding our services into clinical practice and pursuing reimbursement pathways that support long-term sustainability, and we intend to evaluate additional market opportunities in the future.
+Added: • Extend the Zio Platform Into Adjacent Clinical Opportunities.
+Added: We are selectively investing in opportunities that have the potential to extend our core platform into adjacent clinical areas where arrhythmias intersect with other chronic conditions and where our existing capabilities can be leveraged efficiently.
+Added: These include:
◦ Obstructive sleep apnea patients, with an estimated prevalence of approximately 40 million in the United States.
−Removed: Approximately 50% to 80% of patients with Afib may also have sleep apnea compared with 30% to 60% in control groups, and there is a large prevalence of patients with undiagnosed sleep apnea.
+Added: Based on a systematic literature review of original clinical studies published between January 2019 and December2024, approximately 50% of patients with Afib may also have sleep apnea and there is a large prevalence of patients with undiagnosed sleep apnea.
◦ Heart failure patients, with an estimated prevalence of over 8.5 million in the United States by the year 2030.
Atrial fibrillation and heart failure share many antecedent risk factors, and approximately 40% of people with either Afib or heart failure will develop the other condition.
−Removed: Total cost for heart failure in the U.S.
+Added: Total costs for heart failure in the U.S.
are expected to reach $70 billion by 2030.
−Removed: • Patients with hypertension, with an estimated prevalence of over 120 million in the United States.
+Added: ◦ Patients with hypertension, with an estimated prevalence of over 120 million in the United States in 2020.
Up to 90% of patients with Afib may also have hypertension.
−Removed: • Advancing our system portfolio and core technology offering .
−Removed: We continue to invest in building a unique, innovative system portfolio and digital platform that addresses unmet needs in the ACM market and adjacent markets.
−Removed: We will continue to invest in research and development efforts to further differentiate our biosensor, data analytics and reporting, our information system, and our digital platform.
−Removed: We intend to make improvements in Zio MCT Services during 2025, and we also intend to continue evaluating potential opportunities to leverage our PPG algorithms and ZEUS System with a PPG-based wearable platform in the future.
−Removed: Additionally, in 2024 we entered into an exclusive license agreement with BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, to develop and commercialize their patented pulse oximetry, accelerometry and trending non-invasive blood pressure technologies for use within the ACM market.
−Removed: By incorporating medical grade, connected, multi-sensor capabilities, we believe iRhythm will be well positioned to deliver broad clinical insights within ACM that improve patient outcomes, enhance clinical and operational efficiency, and reduce costs to the healthcare system.
+Added: Our approach to adjacent markets is deliberate and evidence driven.
+Added: We intend to prioritize opportunities that integrate naturally with existing physician workflows, leverage our data and artificial intelligence capabilities, and align with our long-term focus on scalable, disciplined growth.
+Added: We have initiated focused pilots and development efforts that are intended to inform future investment decisions.
+Added: • Advance Our Product Portfolio and Technology Platform.
+Added: We continue to invest in advancing our system portfolio and digital platform to address evolving clinical needs.
+Added: This includes ongoing innovation in our wearable biosensors, data analytics, and reporting capabilities, as well as the development of next-generation mobile cardiac telemetry solutions.
+Added: Our next-generation MCT device, for which a 510(k) application was submitted to FDA in the third quarter of 2025, is designed to enhance patient and physician experience through improved form factor, extended wear duration, enhanced detection algorithms, and richer clinical insights.
+Added: We also continue to evaluate opportunities to incorporate additional sensing modalities and wearable technologies where they complement our core platform.
Sales and Marketing
−Removed: We directly market our Zio Services in the United States to healthcare professional through our internal organization comprised of sales representatives, field billing specialists, and customer experience representatives.
−Removed: Our sales team focuses on initial introduction of the Zio Services to those participants that are instrumental to the decision-making process for ambulatory cardiac monitoring, which include physician practices and healthcare systems.
−Removed: We also focus on continuing efforts to ensure healthcare professionals are knowledgeable about the clinical benefits and economic value of the Zio Services.
+Added: We directly market our iRhythm Services in the United States to healthcare professional through our internal organization comprised of sales representatives, field billing specialists, and customer experience representatives.
+Added: Our sales team focuses on initial introduction of our iRhythm Services to those participants that are instrumental to the decision-making process for ambulatory cardiac monitoring, which include physician practices and healthcare systems.
+Added: We also focus on continuing efforts to ensure healthcare professionals are knowledgeable about the clinical benefits and economic value of the iRhythm Services.
We continue to invest in our sales force and focus on ensuring we optimize the structure of our U.S.
−Removed: sales organization to expand the current customer account base and support adoption of the Zio Services.
−Removed: We market our Zio Services to a variety of physician specialties including general cardiologists, electrophysiologists, primary care physicians, neurologists, and other physician specialists who diagnose and manage care for patients with arrhythmias.
−Removed: We have found success focusing on integrated delivery networks (“IDNs”), in which large networks of facilities and providers work together to offer a continuum of care to a specific geographic area or market, as well as with risk-bearing entities as our Zio Systems become a key tool in population health management.
+Added: sales organization to expand the current customer account base and support adoption of the iRhythm Services.
+Added: We market our iRhythm Services to a variety of physician specialties including general cardiologists, electrophysiologists, primary care physicians, neurologists, and other physician specialists who diagnose and manage care for patients with arrhythmias.
+Added: We have found success focusing on integrated delivery networks (“IDNs”), in which large networks of facilities and providers work together to offer a continuum of care to a specific geographic area or market, as well as with risk-bearing entities as our iRhythm ACM Systems become a key tool in population health management.
Focusing on sales to these customer programs gives us the opportunity to conduct a holistic sale for health systems interested in making value-based purchasing decisions.
In January 2021, we established a small direct sales and clinical infrastructure in Bagshot, Surrey in England to service the UK market.
−Removed: We have since focused efforts on the introduction of the Zio Services using the Zio XT System into new accounts and market access efforts, in particular through orders made by NHS Trusts and Hospitals.
−Removed: Additionally, we have built a small sales force covering Switzerland, Austria, and the Netherlands.
−Removed: In Japan and Spain, we intend to utilize distributor services.
−Removed: We typically experience reduced revenue during the third quarter, as well as during the year-end holiday season.
−Removed: We believe this is the result of physicians and patients taking vacations and patients electing to delay our monitoring services during the summer months or holidays.
+Added: We have since focused efforts on the introduction of our iRhythm Services using the Zio XT System into new accounts and market access efforts, in particular through orders made by NHS Trusts and Hospitals.
+Added: Additionally, in Europe, we have built a small sales force covering Switzerland, Austria, and the Netherlands, have entered into a relationship with a vendor in the Netherlands to distribute our products in European countries other than Spain and to fulfill customer orders and process returns of devices from European customers.
+Added: In addition, we have entered into a distributor relationship with a vendor in Spain to distribute our products in Spain.
+Added: In Japan, we utilize the services of a third-party distributor to market and sell our products and services, to fulfill customer orders, and to process returns of devices from Japanese customers.
The market for remote cardiac monitoring is competitive, characterized by rapid change resulting from technological advances, scientific discoveries, and other market activities of industry participants.
−Removed: In providing our Zio Services, we compete with BioTelemetry, Inc.
+Added: In providing our iRhythm Services, we compete with BioTelemetry, Inc.
(acquired by Royal Philips), Preventice Solutions, Inc.
(acquired by Boston Scientific, Inc.), and Bardy Diagnostics, Inc.
−Removed: (acquired by Baxter International, Inc.) to offer remote cardiac monitoring technology and also function as diagnostic service providers.
−Removed: We also compete with companies that sell traditional, 24-to-48-hour Holter monitors, including GE Healthcare, Philips Healthcare, and Spacelabs Healthcare Inc., as well as Mortara Instrument, Inc.
−Removed: and Welch Allyn Holdings, Inc.
+Added: (acquired by Hill-Rom Holdings, Inc.
+Added: now part of Baxter International, Inc.) ("BardyDx") to offer remote cardiac monitoring technology and also function as diagnostic service providers.
+Added: We also compete with companies that sell traditional, 24-to-48-hour Holter monitors, including GE Healthcare, Philips Healthcare, and Spacelabs Healthcare Inc., as well as Welch Allyn Holdings, Inc.
+Added: ("Welch Allyn") and Mortara Instrument, Inc.
(both acquired by Hill-Rom Holdings, Inc.
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Large medical device companies may continue to acquire or form alliances with these smaller companies to diversify their product offering and participate in the digital health space.
−Removed: These competitors and potential competitors may introduce new products and services that more directly compete with our Zio Services and Zio Systems.
+Added: These competitors and potential competitors may introduce new products and services that directly or indirectly compete with our iRhythm Services and iRhythm ACM Systems.
Future competition may also come from manufacturers of wearable fitness products or large information technology companies focused on general health and wellness.
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• contracted rates with third-party payors;
−Removed: • government reimbursement rates associated with our Zio Services and supporting Zio Systems;
+Added: • government reimbursement rates associated with our iRhythm Services and supporting iRhythm ACM Systems;
• quality of clinical data and publications in peer-reviewed journals;
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Manufacturing and Quality Assurance
−Removed: We currently manufacture our Zio Systems, including the Zio Monitor System and Zio AT System, in our leased facility in Cypress, California.
−Removed: This manufacturing facility is approximately 34,000 square feet and provides space for our manufacturing and production operations, including inspection, assembly, testing, packaging, labeling, storage, and shipping.
+Added: We currently manufacture our iRhythm ACM Systems, including the Zio monitor System and Zio AT System, in our leased facility in Cypress, California.
+Added: This facility is approximately 69,000 square feet (of which 34,000 square feet is used for manufacturing) and provides space for our manufacturing and production operations, including inspection, assembly, testing, packaging, labeling, storage, and shipping.
We believe this manufacturing facility has the capacity to meet our manufacturing needs for at least the next five years.
−Removed: Outside suppliers are the source for components and sub-assemblies in the production of the Zio Systems.
−Removed: Any significant supplier of a critical component, such as the circuit boards for the Zio Systems provided by contract electronic manufacturers, is managed through our manufacturing team that is focused on reducing supply chain risk.
+Added: Outside suppliers are the source for components and sub-assemblies in the production of the iRhythm ACM Systems.
+Added: Any significant supplier of a critical component, such as the circuit boards for the iRhythm ACM Systems provided by contract electronic manufacturers, is managed through our manufacturing team that is focused on reducing supply chain risk.
These suppliers are evaluated, approved, and monitored by our quality team to ensure conformity with the specifications, policies, and procedures applicable to our devices.
−Removed: Our manufacturing operations are subject to regulatory requirements of FDA’s Quality System Regulation (“QSR”), the Medical Devices Regulation 2017/745 of the European Parliament and of the Council (“EU MDR”), the UK Medical Device Regulations 2002 (“UK MDR”), and the Japanese medical device Quality Management System ("QMS").
+Added: Our manufacturing operations are subject to regulatory requirements of FDA (including those in its implementing regulations of the Food, Drug, and Cosmetic Act, the Quality System Regulation, which amendments took effect February 2, 2026, with the updated regulations referred to as the Quality Management System Requirements or "QMSR"), the Medical Devices Regulation 2017/745 of the European Parliament and of the Council (“EU MDR”), the UK Medical Device Regulations 2002 (“UK MDR”), and the Japanese medical device Quality Management System ("QMS").
We are also subject to applicable requirements relating to the environment, waste management, and health and safety matters, including measures relating to the release, use, storage, treatment, transportation, discharge, disposal, sale, labeling, collection, recycling, treatment, and remediation of hazardous substances.
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We have registered our device establishments with FDA and with the UK’s Medicines & Healthcare products Regulatory Agency (“MHRA”).
−Removed: Additional EU registrations may be sought in 2025 in EU member states by our EU authorized representative as appropriate.
+Added: Additional EU registrations may be sought in EU member states in the future by our EU authorized representative as appropriate.
Third-Party Reimbursement
−Removed: We receive revenue for the Zio Services primarily from third-party payors, which include commercial payors and government agencies, such as the Centers for Medicare & Medicaid Services (“CMS”).
+Added: We receive revenue for the iRhythm Services primarily from third-party payors, which include commercial payors and government agencies, such as the CMS.
Third-party payors require us to identify the service for which we are seeking reimbursement by using a Current Procedural Terminology (“CPT”) code set maintained by the American Medical Association (“AMA”).
−Removed: These CPT codes are subject to periodic change and update, which will impact the reimbursement rates for our Zio Services.
+Added: These CPT codes are subject to periodic change and update, which will impact the reimbursement rates for our iRhythm Services.
For the year ended December 31, 2025, we received approximately 83% of our revenue through third-party payors, which includes approximately 24% of our total revenue from the Medicare program.
As we continue to contract with more commercial payors and the patient population ages into eligibility for the Medicare Advantage program, we believe more of our revenue will convert to commercial payor billing.
−Removed: Our clinical centers are enrolled in the Medicare program as IDTFs, which allows us to bill CMS directly for our Zio Services.
−Removed: To maintain enrollment, we must meet the CMS IDTF supplier standards, including having an independent medical director for oversight and qualified technicians who support the analysis of ECG data captured by the Zio patches as part of our Zio Services.
−Removed: For additional information on third-party reimbursement, please see our Risk Factor titled “If reimbursement or other payment for our Zio Services is reduced or modified in the United States, including through cost containment measures or changes to policies with respect to coding, coverage, and pricing, our business could suffer.”
+Added: Our clinical centers are enrolled in the Medicare program as IDTFs, which allows us to bill CMS directly for our iRhythm Services.
+Added: To maintain enrollment, we must meet the CMS IDTF supplier standards, including having an independent medical director for oversight and qualified technicians who support the analysis of ECG data captured by the Zio patches as part of our iRhythm Services.
+Added: For additional information on third-party reimbursement, please see our Risk Factor titled “If reimbursement or other payment for our iRhythm Services is reduced or modified in the United States, including through cost containment measures or changes to policies with respect to coding, coverage, and pricing, our business could suffer.”
Research and Development
−Removed: We focus our research and development efforts on improvement of our Zio System and Zio Services in alignment with our strategy.
−Removed: We employ engineering and research and development staff to focus on delivering future innovations and sustaining improvements.
+Added: We focus our research and development efforts on the ongoing development and expansion of patch-based monitoring devices and related services in alignment with our strategy.
+Added: We employ engineering and research and development staff to focus on sustaining achieved improvements as well as delivering future innovations.
Our research and development activities are focused on:
• Continuous improvement and extensions to existing products and services.
−Removed: We are continuously working to improve the Zio Services to increase patient comfort, product quality, operational scalability, and security.
+Added: We are continuously working to improve our devices and services to increase patient comfort, improve product quality and operational scalability, and enhance security.
• International expansion .
−Removed: We are working on building our infrastructure and ensuring global compliance as we identify appropriate opportunities for international growth.
+Added: We are working on expanding our infrastructure and ensuring global regulatory compliance as we identify appropriate opportunities for international growth.
• Advancing our technology offering.
−Removed: Our product portfolio includes patch-based solutions (utilized in the Zio Monitor System, Zio AT System, and Zio XT System) and the FDA-cleared Zio Watch (not yet commercially available) that combine continuous monitoring for extended periods with accelerated notification of significant events through mobile transmission capabilities.
+Added: Our product portfolio includes patch-based solutions (utilized in our existing Zio monitor System, Zio AT System, and Zio XT System) and is planned to include the pending Zio MCT device for which we submitted an application to FDA in 2025.
+Added: We continue to explore wearable solutions as well as patch-based sensors with additional parameters beyond ECG, but these solutions are in development and will require future FDA clearances and other approvals.
• Customer workflow optimization .
−Removed: We have initiatives that aim to increase customer productivity by optimizing workflow through easier patient enrollment, report access, and interpretation, in addition to integrating the reports from our Zio Services directly into EHRs.
+Added: We have initiatives that aim to increase customer productivity by optimizing workflow through easier patient enrollment, report access, and interpretation, in addition to integrating the reports from our iRhythm Services directly into EHRs.
• Data analytics.
−Removed: We are focused on improving and enhancing our back-end, deep-learning analytic platform, building on our core competency in data analytics.
+Added: We are focused on improving and enhancing our back-end, deep-learning analytic platform, building on our core competency in data analytics to drive improved speed and accuracy.
• Developing clinical evidence .
−Removed: We frequently provide support to third parties conducting clinical studies that further support the benefits of the Zio System, including clinical research in areas such as obstructive sleep apnea, hypertension, predictive features, and patient wearables.
+Added: We frequently provide support to third parties conducting clinical studies that further support the benefits of the iRhythm ACM Systems, including clinical research in areas such as obstructive sleep apnea, hypertension, predictive features, and patient wearables.
• Continuing to solidify our footprint in digital healthcare.
−Removed: Using our repository of ambulatory ECG patient data, we will continue to look for ways to create value-driving opportunities in digital healthcare, such as expansion of indications for the Zio System, new therapeutic discoveries, development of an analytical engine for ambulatory consumers, other medical data and payor and provider decision support, and the potential for more complete system integration with large health systems.
−Removed: We have supported clinical studies conducted by leading physicians and clinicians to explore and develop new techniques and applications for our Zio Systems, the clinically-integrated version of ZEUS for the Zio Watch, and other clinical and research activities, including healthcare economic outcomes research.
+Added: Using our repository of ambulatory ECG patient data, as well as our partnerships in the broader chronic disease space, we will continue to look for ways to create value-driving opportunities in digital healthcare, such as expansion of indications for the iRhythm ACM Systems, new therapeutic discoveries, development of an analytical engine for ambulatory consumers, other medical data and payor and provider decision support, and the potential for more complete system integration with large health systems.
+Added: We have supported clinical studies conducted by leading physicians and clinicians to explore and develop new techniques and applications for our iRhythm ACM Systems, and other clinical and research activities, including healthcare economic outcomes research.
Our research and development activities consist of software development, algorithm and product development, regulatory affairs, and clinical research.
−Removed: Our research and development expenses (excluding in-process research and development) were $71.5 million, $60.2 million, and $46.6 million for the years ended December 31, 2024, 2023, and 2022, respectively.
+Added: Our research and development expenses (excluding acquired in-process research and development) were $84.6 million, $71.5 million, and $60.2 million for the years ended December 31, 2025, 2024, and 2023, respectively.
Technology License Agreement with BioIntelliSense, Inc.
−Removed: On August 30, 2024, we entered into a Technology License Agreement (the “License Agreement”) with BioIntelliSense, Inc.
−Removed: (“BioIS”), pursuant to which (i) we will receive a perpetual fully paid up license to certain of BioIS’ intellectual property, technology and products for research, development and commercialization of potential next generation products and services in certain fields of use, including an exclusive license to develop and commercialize pulse oximetry, accelerometry, and trending non-invasive blood pressure technologies for use within our ambulatory cardiac monitoring products and services, and (ii) each party agreed to negotiate in good faith a supply agreement for pulse oximetry hardware.
−Removed: Under the terms of the License Agreement, we paid BioIS an upfront fee of $15.0 million in cash consideration in acceptance of the initial transfer of certain licensed technologies and data following the execution of the License Agreement.
−Removed: In connection with the License Agreement, we also purchased an aggregate of $40.0 million of convertible promissory notes from BioIS (the “Convertible Notes”), of which $20.0 million (“Milestone Notes”) were designated for satisfaction of our regulatory milestone payment obligations.
−Removed: The Milestone Notes, plus accrued and unpaid interest, if any, shall be cancelled, if outstanding, upon the achievement of the regulatory milestones up through December 31, 2026.
−Removed: Additionally, BioIS is eligible to receive low single digit royalty payments on annual net sales of certain products that include licensed rights in the home sleep testing field of use, subject to certain adjustments specified in the License Agreement.
+Added: On August 30, 2024, iRhythm Technologies entered into a Technology License Agreement (as subsequently amended, the “License Agreement”) with BioIntelliSense, Inc.
+Added: (“BioIS”), pursuant to which (i) iRhythm Technologies will receive a perpetual fully paid up license to certain of BioIS’ intellectual property, technology and products for research, development and commercialization of potential next generation products and services in certain fields of use, including (x) an exclusive license to develop and commercialize pulse oximetry, accelerometry, and trending non-invasive blood pressure technologies for use within our ambulatory cardiac monitoring products and services and (y) a limited, non-exclusive license to develop and commercialize products and services for use in unattended, home-based diagnostic testing and assessment of sleep apnea, and (ii) iRhythm Technologies and BioIS agreed to negotiate in good faith a supply agreement for pulse oximetry hardware.
+Added: Under the terms of the License Agreement, iRhythm Technologies paid BioIS an upfront fee of $15.0 million in cash consideration in acceptance of the initial transfer of certain licensed technologies and data following the execution of the License Agreement.
+Added: In connection with the License Agreement, iRhythm Technologies also purchased an aggregate of $40.0 million of convertible promissory notes from BioIS (the “Convertible Notes”), of which $20.0 million (“Milestone Notes”) were designated for satisfaction of our regulatory milestone payment obligations.
+Added: The Milestone Notes, plus accrued and unpaid interest, if any, shall be cancelled, if outstanding, upon the achievement of these regulatory milestones up through December 31, 2026.
+Added: In June 2025, BioIS achieved the first of two regulatory milestones.
+Added: As of December 31, 2025, we and BioIS are in the process of completing all required contractual conditions to cancel $10.0 million in Milestone Notes plus accrued and unpaid interest.
Intellectual Property
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As of December 31, 2025, we owned, or retained an exclusive license to, 59 issued patents from the U.S.
−Removed: Patent Office (“USPTO”), 13 issued patents from the Japanese Patent Office, 4 issued patents from the Australian Patent Office, 5 issued patents from the Canadian Patent Office, 7 issued patents from the European Patent Offices, 6 issued patents from the Korean Patent Office, two issued patents from the Chinese Patent Office, and 1 issued patent from the Indian Patent Office.
+Added: Patent Office (“USPTO”) (comprised of 55 Utility patents and 4 Design patents), 16 issued patents from the Japanese Patent Office, seven issued patents from the Australian Patent Office, five issued patents from the Canadian Patent Office, seven issued patents from the European Patent Office (validated and providing protections in the countries of Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Spain, Sweden, Switzerland, the UK, and the Unitary Patent Court), seven issued patents from the Korean Patent Office, four issued patents from the Chinese Patent Office, and one issued patent from the Indian Patent Office.
issued patents as of December 31, 2025, are set to expire over a range of years, from November 2028 to August 2041, subject to any extensions.
−Removed: As of December 31, 2024, we had 50 pending patent applications globally, including 14 non-provisional applications and 2 design applications in the United States, 7 in the European Patent Office, 8 in Japan, 1 Patent Cooperation Treaty ("PCT") international application, 5 in Korea, 4 each in Australia and China, 3 in India, and 2 in Canada.
+Added: As of December 31, 2025, we had 65 pending patent applications globally, including 22 non-provisional applications in the United States, eight applications in the European Patent Office, six applications in Japan, twelve Patent Cooperation Treaty ("PCT") International applications, four applications in Korea, three applications in each of China and India, two applications in Canada, and one application in Australia.
Our patents and patent applications seek to protect aspects of our core technologies and our product concepts for ambulatory cardiac monitoring.
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However, our patent applications may not result in issued patents, and any patents that have been issued or might be issued may not protect our intellectual property rights.
+Added: We are currently party to patent litigation initiated by Welch Allyn and BardyDx as further described under "Legal Proceedings" and we cannot predict the outcome of such litigation.
We also rely on trade secrets, technical know-how, and continuing innovation to develop and maintain our competitive position.
−Removed: As of December 31, 2024, our trademark portfolio contained U.S.
−Removed: trademark registrations for the marks MyZIO, ZIO, ZIO SUITE, ZIO AT, and IRHYTHM and pending U.S.
−Removed: trademark applications for the marks KNOW YOUR RHYTHM BY ZIO, KNOW YOUR RHYTHM, and ZIO MCT.
−Removed: It also contained registered trademarks for the mark IRHYTHM in Australia, the EU, Austria, Canada, China, Denmark, Finland, France, Germany, Japan, Italy, Norway, Sweden, Switzerland, and the UK.
−Removed: It further contained trademark registrations for the mark ZIO in Australia, Canada, China, the EU, Japan, Norway, Switzerland, and the UK.
−Removed: It also contained trademark registrations for the mark MYZIO in Canada, the UK, and the EU, trademark registrations for the mark ZIO MCT in the UK and the EU, and trademark registrations for the mark ZIOSUITE in the UK and the EU.
+Added: As of December 31, 2025, our trademark portfolio contained (i) U.S.
+Added: trademark registrations for the marks IRHYTHM, KNOW YOUR RHYTHM, ZIO, MYZIO, ZIO SUITE, and ZIO AT and one pending U.S.
+Added: trademark application for the mark ZIO MCT, (ii) registered trademarks for the mark IRHYTHM in the EU, Australia, Austria, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Norway, Sweden, Switzerland, and the UK, (iii) trademark registrations for the mark ZIO in the EU, Australia, Canada, China, Japan, Norway, Switzerland, and the UK, (iv) trademark registrations for the mark MYZIO in the EU, Canada, the UK, (v) trademark registrations for the mark ZIO MCT in the EU, Japan, Switzerland, and the UK, and (vi) trademark registrations for the mark ZIOSUITE in the EU and the UK.
Based on the nature of the services we provide, the medical devices used to deliver our services, and the ways in which payment is available for our services, we are subject to a complex spectrum of intersecting laws and regulatory frameworks.
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CMS has set certain performance standards that every IDTF must meet in order to obtain or maintain its billing privileges.
−Removed: We are also regulated as a medical device manufacturer because of our role in the design, development, and manufacturing of the Zio Systems used in our Zio Services.
+Added: We are also regulated as a medical device manufacturer because of our role in the design, development, and manufacturing of the iRhythm ACM Systems used in our iRhythm Services.
The United States has historically been the primary focus of the delivery of our services, but based on our operations we are subject to a range of laws and regulations outside the United States, and we expect the complexity of the global regulatory landscape to which we are subject to continue to increase.
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CMS has established guidelines for the coverage and reimbursement of certain products, supplies, and services, including ambulatory cardiac monitoring services.
−Removed: In general, Medicare will only reimburse ambulatory cardiac monitoring services, such as our Zio Services, that are reasonable and necessary for the diagnosis or treatment of patients.
+Added: In general, Medicare will only reimburse ambulatory cardiac monitoring services, such as our iRhythm Services, that are reasonable and necessary for the diagnosis or treatment of patients.
CMS also administers the Medicaid program, a cooperative federal/state program that provides medical assistance benefits to qualifying low income and medically needy persons.
State participation in Medicaid is optional, and each state is given discretion in developing and administering its own Medicaid program, subject to certain federal requirements.
−Removed: All CMS programs are subject to statutory and regulatory changes, retroactive and prospective rate adjustments, administrative rulings, interpretations of policy, intermediary determinations, and government funding restrictions, all of which may materially increase or decrease the rate of program payments to healthcare facilities and other healthcare providers, including those paid for our Zio Services.
+Added: All CMS programs are subject to statutory and regulatory changes, retroactive and prospective rate adjustments, administrative rulings, interpretations of policy, intermediary determinations, and government funding restrictions, all of which may materially increase or decrease the rate of program payments to healthcare facilities and other healthcare providers, including those paid for our iRhythm Services.
Because of the significant federal funding involved, the government actively enforces a number of laws and regulations to eliminate fraud and abuse in federal healthcare programs.
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The federal government has used the FCA to assert liability on the basis of inadequate care, kickbacks, and other improper referrals, and improper use of CMS billing numbers, as well as allegations of off-label promotion of products, and activities relating to the reporting of discount and rebate information.
−Removed: The FCA is the federal government’s preferred enforcement vehicle for addressing a variety of alleged misconduct and provides for treble damages and civil money penalties ranging from $13,508 to approximately $27,018 per claim, as well as exclusion from participation in federal healthcare programs and potential criminal penalties, including imprisonment and criminal fines.
−Removed: Additionally, as part of any settlement, the government will often require the entity to enter into a corporate integrity agreement, which imposes certain ongoing compliance, certification, and reporting obligations.
+Added: The FCA is the federal government’s preferred enforcement vehicle for addressing a variety of alleged misconduct and provides for treble damages and civil money penalties ranging from $14,308 to $28,619 per claim as of July 3, 2025.
+Added: Individuals and entities can also face exclusion from participation in federal healthcare programs and potential criminal penalties, including imprisonment and criminal fines.
+Added: Additionally, as part of any settlement, the government will occasionally require the entity to enter into a corporate integrity agreement, which imposes certain ongoing compliance, certification, and reporting obligations.
In addition, various states have enacted false claims laws analogous to the FCA, and many of these state laws apply where a claim is submitted to any third-party payor and not only a federal healthcare program.
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These laws and regulations may change, and additional implementation regulations are expected for the No Surprises Act, and we anticipate these requirements may apply to our business in the future.
−Removed: We are subject to risks related to the U.S.
−Removed: fraud and abuse laws and other healthcare compliance requirements described above, as well as others that are or may be adopted in future.
+Added: We are subject to risks related to U.S.
+Added: and international fraud and abuse laws and other healthcare compliance requirements described above, as well as others that are or may be adopted in future.
For further details on these risks, see “Risk Factors,” below.
Food and Drug Administration
−Removed: Because we develop and manufacture the medical device technology used in the Zio Services (the hardware and software elements that FDA regulates as “devices”), we are subject to extensive and ongoing regulation by FDA under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and its implementing regulations, as well as other federal and state regulatory bodies in the United States.
+Added: Because we develop and manufacture the medical device technology used in the iRhythm Services (the hardware and software elements that FDA regulates as “devices”), we are subject to extensive and ongoing regulation by FDA under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and its implementing regulations, as well as other federal and state regulatory bodies in the United States.
The laws and regulations govern, among other things, product design and development, preclinical and clinical testing, manufacturing, packaging, labeling, storage, recordkeeping and reporting, clearance or approval, marketing, distribution, promotion, import and export, and post-marketing surveillance and associated regulatory reporting.
−Removed: Most Class II devices, including the Zio patches and the ZEUS System, require 510(k) clearance from FDA in order to be marketed in the United States.
+Added: Most Class II devices, including Zio monitor, Zio AT, Zio XT, ZEUS and the Zio MCT device for which we are seeking marketing authorization, require 510(k) clearance from FDA in order to be marketed in the United States.
A 510(k) submission must demonstrate that the device is substantially equivalent to a device legally in commercial distribution in the United States.
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These include:
−Removed: • the FDA’s QSR, which requires manufacturers, including their suppliers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the product lifecycle, including the manufacturing process;
+Added: • FDA’s QMSR, which requires manufacturers, including their suppliers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all aspects of the product lifecycle, including the manufacturing process;
• labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved, or off-label uses, including parameters around manufacturer communications with payors and healthcare professionals;
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FDA requires each manufacturer to make this determination initially, but FDA can review any such decision and can disagree with a manufacturer’s determination.
−Removed: If FDA disagrees with the determination not to seek a new 510(k) clearance or PMA approval, the FDA may retroactively require a new 510(k) clearance or PMA approval.
+Added: If FDA disagrees with the determination not to seek a new 510(k) clearance or PMA approval, FDA may retroactively require a new 510(k) clearance or PMA approval.
FDA could also require a manufacturer to cease marketing and distribution and/or recall the modified device until 510(k) clearance or PMA approval is obtained.
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FDA and the CDPH have broad post-market and regulatory enforcement powers.
−Removed: We are subject to unannounced inspections by FDA and the Food and Drug Branch of CDPH to determine our compliance with the QSR and other regulations, and these inspections may include the manufacturing facilities of our suppliers.
+Added: We are subject to unannounced inspections by FDA and the Food and Drug Branch of CDPH to determine our compliance with FDA's QMSR and other regulations, and these inspections may include the manufacturing facilities of our suppliers.
Failure to comply with applicable regulatory requirements can result in enforcement action by FDA, which may include any of the following sanctions:
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For further details on these risks, see “Risk Factors” below.
+Added: The manner in which these risks present may also be impacted by the changing enforcement landscape, including in relation to reorganization under current administration policies.
+Added: For example, DOJ has used both criminal and civil mechanisms to enforce the FD&C Act through the Consumer Protection Branch (“CPB”) of DOJ.
+Added: Following dissolution of the CPB, on September 25, 2025, DOJ announced a restructuring under which the Civil Division’s litigation work would be consolidated into a new Enforcement & Affirmative Litigation Branch, and the Health and Safety Unit housed within the Fraud Section of DOJ’s Criminal Division is now charged with criminal enforcement of the FD&C Act.
Privacy and Security Regulation
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Since May 2021, the EU MDR has been the relevant regulatory framework for devices in the EU, replacing the prior Medical Device Directive.
−Removed: The Zio Monitor System and the Zeus System are currently marked in the EU under our CE mark under the EU MDR issued by the British Standards Institution ("BSI") in December 2023.
+Added: The Zio monitor System and ZEUS are currently marked in the EU under our CE mark under the EU MDR issued by the British Standards Institution ("BSI") in December 2023.
National competent authorities in each member state of the EU oversee the implementation of the EU MDR within their jurisdiction, typically through so-called notified bodies which are certification organizations designated by a member state to conduct third-party conformity assessments (the “Notified Bodies”).
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It covers most goods which previously required the CE marking, including medical devices.
−Removed: The UKCA requirement became effective on January 1, 2021, and we have obtained a UKCA mark with the BSI, which also serves as our UK Approved Body, for the Zio XT System and the Zeus System.
+Added: The UKCA requirement became effective on January 1, 2021, and we have obtained a UKCA mark with the BSI, which also serves as our UK Approved Body, for Zio XT and ZEUS.
We are also registered with the UK’s Care Quality Commission to carry out diagnostic and screening procedures.
Additionally, the EU Notified Body and UK Approved Body regularly audit our manufacturing, design, and operational facilities to ensure ongoing ISO 13485 and EU MDR compliance and periodically audit technical design files in accordance with the EU MDR in order to maintain our CE mark or issue a CE mark or UKCA mark for new or updated devices.
+Added: Regulatory authorities in Japan include the Ministry of Health, Labor and Welfare ("MHLW"), which defines policy, issues medical device approvals and enforces regulations;
+Added: and the PMDA which reviews device applications, conducts scientific assessments and monitors post-market device safety.
+Added: The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the "PMD Act") is the principal legislation in Japan governing Medical Devices that provides a comprehensive regulatory framework such as marketing authorization, business licenses, labeling and advertising regulations.
+Added: Devices are classified in accordance with their perceived risks, similarly to the U.S.
+Added: and EU systems.
+Added: Zio monitor and ZEUS (known in Japan as Zio ECG Recording and Analysis System) were approved by MHLW in September 2024 and Zio monitor is currently marketed in Japan.
+Added: In addition to product approval, we and other foreign manufacturers must appoint a Japan-based Designated Marketing Authorization Holder ("DMAH") to be the Regulatory and Quality Management System ("QMS") representative to MHLW for pre- and post-market activities.
+Added: MHLW Ordinance No.
+Added: 169 governs QMS requirements, largely aligned with ISO 13485:2016 with other Japan-specific provisions and has been incorporated into iRhythm's internal quality management system.
Anti-Bribery and Anti-Corruption Laws
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We believe that immense possibility exists at iRhythm, so we are open to embracing change and pursuing opportunities for growth, and we seek diverse perspectives in that pursuit.
−Removed: In accordance with these values, we believe that effectively managing environmental, social, and corporate governance (“ESG”) risks and opportunities drives business success and that, when fully integrated into the business, ESG can provide a competitive advantage.
−Removed: During 2024, we refreshed our ESG priority assessment to ensure we are aligning with the issues that matter most to our business and stakeholders.
−Removed: We made significant progress in many aspects of our ESG strategy, including:
−Removed: • Expanded measurement of Greenhouse Gas Emissions to include Scope 3 in addition to Scope 1 and 2 measurements;
−Removed: • Obtained ISO 14001:2015 Environmental Management System Certification for our manufacturing facility in Cypress, CA;
−Removed: • Completed a Life Cycle Analysis to further assess the environmental impacts of our products;
−Removed: • Published supplier code of conduct and conflict minerals policies on our website;
−Removed: • Expanded patient access to Zio by launching commercially in Spain, Switzerland, Austria and The Netherlands;
−Removed: • Added one new employee resource group for iRhythm employees to further build an inclusive culture that empowers and engages all employees.
+Added: In accordance with these values, we believe that effectively managing sustainability risks and opportunities drives business success and that, when fully integrated into the business, sustainability can provide a competitive advantage.
+Added: In 2024, we refreshed our sustainability priority assessment to ensure we are aligning with the issues that matter most to our business and stakeholders and, in 2025, we released a refreshed corporate sustainability report to highlight our progress against these priorities.
+Added: We made significant progress in many aspects of our sustainability strategy, including:
+Added: • Enhancing our quality systems, improved customer experience through EHR integration and innovative product launches, and securing strategic technology licensing agreements to advance connected patient care;
+Added: • Refreshing our core values to define the culture we would like to shape going forward;
+Added: • Receiving regulatory approval from the PMDA for the Zio fourteen-day, long-term continuous ECG monitoring system in Japan, the world’s second largest market for ambulatory cardiac monitoring (ACM) in 2025;
+Added: • Completing our Scope 3 greenhouse gas emissions inventory and achieving 89.5% landfill waste diversion;
+Added: • Improving access by launching in Austria, the Netherlands, Spain and Switzerland;
+Added: • Revising our code of conduct to provide employees with the resources and guidance needed to operate with unquestionable integrity.
Human Capital
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Our approach is designed to empower our global workforce, fostering flexibility and productivity while maintaining a strong company culture.
−Removed: The Compensation and Human Capital Management Committee of our Board of Directors has oversight of our culture and human capital management.
Inclusion and Belonging
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Board and Management Oversight
−Removed: The Compensation and Human Capital Management Committee of our Board of Directors has oversight of human capital management, including our approach to talent recruiting, development, progression and retention, culture, human health and safety, and total rewards.
+Added: The compensation and human capital management committee of our board of directors has oversight of our culture and human capital management, including our approach to talent recruiting, development, progression and retention, culture, human health and safety, and total rewards.
We are committed to nurturing our workforce and have also established a Global Leadership Forum that is led by our Executive Leadership Team to ensure broader alignment across our organization's leadership on key corporate initiatives, company culture, and transformation objectives.
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We believe that to date we have materially complied with applicable health, safety, and environmental laws as well as related company policies and procedures and provide necessary training as appropriate by role and location.
−Removed: During 2023, we published internally our Environmental, Health, and Safety Policy Statement demonstrating our ongoing commitment to the highest standards of environmental, health, and safety performance.
+Added: In 2023, we published internally our Environmental, Health, and Safety Policy Statement demonstrating our ongoing commitment to the highest standards of environmental, health, and safety performance.
We consistently track and evaluate recordable incident rates associated with our various facilities locations.
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We believe that we offer our employees competitive benefits that follow industry standards and support physical, mental, and financial wellness.
−Removed: We offer health benefits, a 401(k) plan with company match, paid time off and family leave, an Employee Stock Purchase Plan for employees in the United States, which allows them to purchase our stock at a discount, and an employee wellness program that is generally available to employees and their families globally with a variety of support services.
+Added: We offer health benefits, a 401(k) plan with company match, paid time off and family leave, an Employee Stock Purchase Plan for employees in the United States and the United Kingdom, which allows them to purchase our stock at a discount, and an employee wellness program that is generally available to employees and their families globally with a variety of support services.
Workforce Development
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.