What changed in this filing

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Item 1. Business

2025-03-06 compared with 2024-03-01 · 77 added, 90 removed, 467 unchanged (26% of the section changed)

IRADIMED CORPORATION (“IRadimed”, the “Company,” “we,” “us,” “our” or similar terms) develops, manufactures, markets and distributes Magnetic Resonance Imaging (“MRI”) compatible medical devices and related accessories, disposables and services relating to them.

We were incorporated in Oklahoma in July 1992 and reincorporated in Delaware in April 2014.

We were originally incorporated in Oklahoma under the name IRI Development, Inc.

in 1992, and we merged our Oklahoma corporation into the newly formed Delaware corporation in April 2014.

MRidium 3860+ MRI Compatible IV Infusion Pump System

We are the only known provider of a non-magnetic intravenous (“IV”) infusion pump system that is specifically designed to be safe for use during MRI procedures.

We are the only known provider of a non-magnetic intravenous (“IV”) infusion pump system that is specifically designed to be safe for use during MRI procedures and operates dependably in magnetic fields up to 10,000 gauss.

We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures.

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wireless blood oxygen saturation monitoring (“SpO2”) using Masimo® algorithms;

non-magnetic respiratory CO2;

non-magnetic respiratory carbon dioxide (“CO2”);

invasive and non-invasive blood pressure;

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With the expanding use of MRI procedures, both traditional procedures, and intraoperative and interventional procedures, safe and reliable infusion delivery and patient monitoring in an MRI environment is becoming increasingly important to hospitals and other medical providers.

Our founder, President, Chief Executive Officer, and Chairman of the Board of Directors, Roger Susi, is a pioneer in the MRI compatible medical device industry, having invented the first MRI compatible patient monitoring system in 1986 and the first non-magnetic MRI compatible IV infusion system in 2004.

Our founder, President, Chief Executive Officer, and Chairman of our Board of Directors (the “Board” or the “Board of Directors”), Roger Susi, is a pioneer in the MRI compatible medical device industry, having invented the first MRI compatible patient monitoring system in 1986 and the first non-magnetic MRI compatible IV infusion system in 2004.

We sell our products primarily to hospitals and acute care facilities, both in the United States and internationally.

We currently employ a direct sales strategy in the United States and as of December 31, 2023, our direct sales force consisted of 25 field sales representatives, supported by 3 regional sales directors, and supplemented by 7

clinical application specialists.

We currently employ a direct sales strategy in the United States and as of December 31, 2024, our direct

sales force consisted of 27 field sales representatives, supported by 4 regional sales directors, and supplemented by 10 clinical application specialists.

Internationally, we market our products into approximately 80 countries through the use of independent distributors.

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In fiscal year 2024, our revenue was $73.2 million and our income from operations was $22.0 million representing an operating profit margin of 30 percent.

Refer to the information contained under the caption “Financial Highlights and Outlook” regarding our outlook for 2024.

Our internet website is www.iradimed.com.

We make available on the Investors section of our website, free of charge, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and Proxy Statements, and amendments to those reports, as soon as reasonably practicable after filing such documents with, or furnishing such documents to, the SEC.

We include our website address throughout this filing for reference only.

The information contained on our website is not incorporated by reference to this report.

Refer to the information contained under the caption “Financial Highlights and Outlook” regarding our outlook for fiscal year 2025.

History and Development

Susi founded Invivo Research Inc.

in 1979 where he developed the first MRI compatible patient monitoring system.

Susi served as the President of Invivo Research Inc.

from 1979 until 1998, and as its Chairman of the Board of Directors from 1998 until 2000.

(“Invivo Research”) in 1979 where he developed the first MRI compatible patient monitoring system.

Susi served as the President of Invivo Research from 1979 until 1998, and as its Chairman of the Board of Directors from 1998 until 2000.

Susi’s leadership, Invivo Research matured from a start-up medical device company into a leading producer of vital signs monitoring devices used during MRI procedures.

Invivo Research Inc.

was acquired by Invivo Corporation (“Invivo”) in 1992, which began trading on the Nasdaq Capital Market (“Nasdaq”) in 1994.

Susi served as a Director of Invivo Corporation from 1998 until 2000 and oversaw technical areas from 2000 to 2004.

Invivo Corporation was acquired by Intermagnetics General Corporation in 2004, which was later acquired by Koninklijke Philips NV (NYSE:

Invivo Research was acquired by Invivo Corporation (“Invivo”) in 1992, which began trading on the Nasdaq Capital Market in 1994.

Susi served as a Director of Invivo from 1998 until 2000 and oversaw technical areas from 2000 to 2004.

Invivo was acquired by Intermagnetics General Corporation in 2004, which was later acquired by Koninklijke Philips NV (NYSE:

Susi began exploring the market for an MRI compatible IV infusion pump while at Invivo.

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In 2014, we began developing our own MRI compatible patient vital signs monitoring system (“3880 Monitor”).

Using current and new technologies, and our trade secrets, we believe our 3880 Monitor improves on the design of other MRI compatible vital signs monitors.

Using current and new technologies, and our trade secrets, we believe our 3880 Monitor improves on the design of competitive MRI compatible vital signs monitors.

Our 3880 Monitor is compact and lightweight, overcoming many of the workflow issues created by other larger and heavier MRI compatible monitors currently in the market.

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In 2022, we introduced our ferromagnetic detection device, IRadimed FMD1 3600 with Remote Alarm Logging Unit, (“RALU”).

This is the first ferromagnetic detection device with Tru Sense TM threat qualification technology.

This technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and Zone IV door status reducing false alarms, all while simultaneously circumventing background magnetic field noise.

This is the first ferromagnetic detection device with Tru Sense TM threat qualification technology for MRI safety strategy in hospitals.

This technology predicts an approaching ferrous hazard by uniquely

sensing a threat’s speed, trajectory, and Zone IV door status reducing false alarms, all while simultaneously circumventing background magnetic field noise.

We currently compete in the MRI compatible medical device market.

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Further, there are risks in using a standard IV infusion pump that is mistakenly believed to be at a safe distance from the MR scanner.

The powerful magnetic fields may cause metal objects in the MR environment to be drawn with great force into the bore of the MRI system, resulting in potentially deadly projectiles.

The powerful magnetic fields may cause metal objects in the MR environment to be drawn with

great force into the bore of the MRI system, resulting in potentially deadly projectiles.

Moreover, an MRI scanner’s gradient magnetic field and radiofrequency (“RF”) fields can send electrical currents through cables and other conductive materials that are near the MRI system and cause the cables to heat, which may result in burns if they come into contact with the patient or facility staff.

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hospitals (refer to the section below titled “ Expansion of Intra-Hospital Use of MRI Compatible Devices” ).

Based on an estimate of the number of critical care departments in the U.S., we believe there is the potential for the continued sales of our MRI compatible IV infusion pump systems.

Based on an estimate of the number of critical care departments in the U.S., we believe there is the potential for growth in sales of our MRI compatible IV infusion pump systems.

MRI Compatible Patient Vital Signs Monitor

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Based on an estimate the number of critical care departments in the U.S.

and an estimate of the anticipated

adoption rate in these critical care departments, we believe there is potential for additional sales of our MRI vital signs monitoring systems.

and an estimate of the anticipated adoption rate in these critical care departments, we believe there is potential for growth in sales of our MRI vital signs monitoring systems.

Expansion of Intra-Hospital Use of MRI Compatible Devices

Historically, we marketed our MRI compatible devices primarily to the MRI departments of U.S.

We believe, however, based on feedback and historical successes selling our devices, that there is continued potential for expanded deployment of our MRI compatible IV infusion pumps and MRI compatible monitors within the Intensive Care Unit (ICU), Emergency Room (ER), and other critical care departments within U.S.

We believe, however, based on feedback and historical successes selling our devices, that there is potential for expanded deployment of our MRI compatible IV infusion pumps and MRI compatible monitors within the Intensive Care Unit (ICU), Emergency Room (ER), and other critical care departments within U.S.

hospitals where there is a high probability that MRI procedures will need to be performed on these patients.

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Neurosurgical interventions have been at the forefront of this development in image-guided surgery, followed by otolaryngological procedures.

As MR-guided intervention during surgery has been deployed, the degree of complexity in supplemental devices has increased markedly.

As MR-guided intervention during surgery has been deployed, the degree of complexity in supplemental devices has increased markedly potentially introducing additional safety issues for patients.

Much of the effort required for successful implementation of intraoperative MRI has been in development and testing of anesthesia equipment, patient monitoring devices, infusion pumps and surgical instruments and accessories, all of which need to be MRI compatible if used near the MRI scanner.

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Company Objective

Our objective is to become the leader in providing safe and effective care for all patients undergoing MRI procedures through the development and commercialization of a portfolio of MRI compatible products, accessories, disposables, and related services.

Our objective is to be the leader in providing safe and effective care for all patients undergoing MRI procedures through the development and commercialization of a portfolio of MRI compatible products, accessories, disposables, and related services.

By increasing the safety parameters of equipment operating within the harsh magnetic environment of the MRI scanner room, we hope to enable hospitals and other healthcare providers to offer the MRI diagnostic procedures patients require.

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We believe that the largest potential market for our MRI compatible IV infusion pumps is the segment of the market that is currently using workaround solutions.

Such solutions include using conventional pumps outside the MRI scanner room and attaching multiple extension lines of IV tubing sets through the wall or under the door into the MRI scanner room to reach the patient.

Such solutions include using conventional pumps outside the MRI

scanner room and attaching multiple extension lines of IV tubing sets through the wall or under the door into the MRI scanner room to reach the patient.

This practice of makeshift setups is fraught with risks to the patient and unnecessary costs and inefficiencies.

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We intend to leverage this experience and collaboration to innovate and commercialize other technologically advanced MRI compatible patient care products.

The recent introduction of our Ferromagnetic Detection system (“FMD”) is an example of this expansion.

Our 2022 introduction of our Ferromagnetic Detection system (“FMD”) is an example of this expansion.

When reasonably available, acquiring synergistic MRI patient care companies, products, or technology licenses to accelerate our product development and leverage our existing sales organization.

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Commercial Strategy

We believe that the MRI compatible IV infusion pump market continues to have growth potential given the low rate of market penetration, and we aim to drive increased awareness, adoption and utilization of our MRI compatible products by:

We believe that the MRI compatible IV infusion pump market continues to have growth potential and we continue to drive increased awareness, adoption and utilization of our MRI compatible products by:

Continued development of our MRI-focused U.S.

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is the continued development of the market through driving awareness and education by our direct sales force.

Since there is no current direct competitor for an MRI compatible IV infusion pump, our focus is on expanding the market through better education on the advantages to patients, clinicians and hospitals of our infusion pump solution and the shortcomings of current workaround practices.

Since there is no current direct competitor for an MRI compatible IV infusion pump, our focus is on expanding the market through better education on the advantages to patients, clinicians and hospitals of our current and expected infusion pump solutions and the shortcomings of current workaround practices.

Additionally, with our 3880 Monitor, we focus on educating customers on the total workflow benefits our devices offer and how our devices increase the efficiency of MRI scanners via patient throughput.

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Internationally, our focus is to continue working with our distributors in key target markets, such as Europe and Asia, to expand the business and augment our market penetration rates.

As business progress dictates, we plan to expand our internal capacity to serve high potential markets by adding dedicated resources located outside the U.S.

to oversee our relationships at the local level.

As business progress dictates, we plan to expand our staff to serve the largest potential markets outside the U.S.

to build our relationships at the local level.

Supporting commercial efforts with evidence-based information

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To assist in the education process, we have developed materials that document the risks and additional costs associated with using a workaround solution of running long lines from conventional IV pumps outside the MRI scanner room.

We are also continuing the development of and enhancing our materials documenting the benefits of uninterrupted vital signs monitoring that allows for easy transfer of critically ill patients from critical care to the MRI scanner room and back.

We are also continuing the development of and enhancing our materials documenting the benefits of patient-centered care with uninterrupted vital signs monitoring that allows for easy transfer of critically ill patients from critical care to the MRI scanner room and back.

We believe this kind of evidence-based documentation will help us provide widespread education to the clinicians that are driving clinical practice.

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Once a customer purchases our products, it is imperative that they receive first-class clinical education and support to encourage usage of our products.

We devote a significant amount of time and training to ensure

that this educational experience is a success.

We devote a significant amount of time and training to ensure that this educational experience is a success.

This training is usually performed by our sales staff with the frequent assistance of our clinical application specialists.

We intend to hire more clinical application specialists to strengthen our initial training experience and increase ongoing customer support.

We believe that a positive user experience is critical to driving increased rates of utilization of our products.

We believe that a positive user experience is critical to driving increased rates of utilization of our products which can increase sales of disposables.

Typical MRI Scanner Room

The following diagram is representation of an aerial view of a typical MRI scanner room with a typical three Tesla magnet.

The gauss-lines illustrate the distance from the magnet where various types of medical devices can safely operate.

The gauss-lines illustrate the distance from the magnet where various types of medical devices can safely

Our 3880 MRI compatible patient vital signs monitor is the only MRI monitor that can operate safely and reliably in very close proximity to the bore of the powerful magnet used to operate the MRI (area shown in red).

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All other pumps must be placed at a distance from the MRI scanner, which may include being outside of the scanner room entirely.

We currently offer three primary products for sale:

We currently offer three primary products for use in the scanner room:

(1) our MRidium 3860+ MRI compatible IV infusion pump system with associated disposable IV tubing sets, (2) our 3880 MRI compatible patient vital signs monitoring system with associated disposable products, and (3) our 3600 FMD1 with RALU ferromagnetic detection device.

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Our MRidium 3860+ MRI compatible IV infusion pump system offers a dose rate calculator, bolus dose programming, full alarm settings, and a rechargeable battery with a 12-hour life.

MRidium 3860+ IV Tubing Sets

MRidium 3860+ IV Tubing Sets - Disposables

The MRidium 3860+ MRI compatible IV infusion pump system utilizes proprietary fluid delivery tubing sets, each known as an “IV tubing set.” Each use of our MRI compatible IV infusion pump requires a disposable IV tubing set.

We offer a variety of IV tubing sets for varying infusion scenarios and these include our standard “spike” infusion

set, syringe adapter infusion set and extension infusion set.

We offer a variety of IV tubing sets for varying infusion scenarios and these include our standard “spike” infusion set, syringe adapter infusion set and extension infusion set.

Each of our IV tubing sets is latex-free and Di-2-ethylhexyl phthalate (DEHP)-free.

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In addition to our standard product features, we also offer system upgrades, which include a modular add-on second IV channel through our 3861 Side Car, a wireless remote control/display, DERS and an imbedded SpO2 monitor.

We also offer rechargeable lithium polymer battery packs which have 12-hour life when not connected to an electrical outlet.

We also offer rechargeable lithium polymer battery packs which have a 12-hour life when not connected to an electrical outlet.

3861 Side Car Pump Module

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Utilizing the same user interface and large bright display as the MRidium pump, our wireless remote display/control unit permits clinicians to adjust all pump parameters, including SpO2 monitoring parameters, rates, dose, volume, pump run/stop, alarms (adjust or reset), as well as real-time titration.

Our remote display/control unit utilizes a proven MRI compatible 2.4 GHz frequency hopping spread spectrum

radio technology for artifact-free operation that does not disturb the MRI imaging process.

Our remote display/control unit utilizes a proven MRI compatible 2.4 GHz frequency hopping spread spectrum radio technology for artifact-free operation that does not disturb the MRI imaging process.

Clinicians may also use the remote display/control unit to adjust a second pump channel when used in combination with our Side Car unit discussed above.

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With DERS, patient safety and user convenience are supported by user-programmed infusion hard limits (maximum and minimum) and soft limits (high and low limits that require user confirmation to exceed).

The dose applied via DERS is displayed and can be adjusted directly on the running screen at any time during the infusion.

The dose applied via DERS is displayed and can be

adjusted directly on the running screen at any time during the infusion.

The memory card port allows for easy archiving and updating of the drug library.

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The basic configuration of the 3880 Monitor includes wireless ECG with dynamic gradient filtering, wireless SpO2 using Masimo® algorithms, and non-invasive blood pressure.

Optional features include all or a combination of non-magnetic respiratory CO2;

invasive blood pressure;

patient temperature, and/or optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements.

Optional features include all or a combination of non-magnetic respiratory CO2, invasive blood pressure, patient temperature, and/or optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements.

The MRI compatible patient vital signs monitoring system also includes:

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and (3) wireless ECG, SpO2 and invasive blood pressure pods that facilitate the respective monitoring modalities.

IRadimed FMD1 with Remote Alarm Logging Unit (“RALU”)

IRadimed FMD1 with RALU

Our 3600 ferromagnetic detection device, IRadimed FMD1 with RALU is the first ferromagnetic detection device with Tru Sense TM threat qualification technology.

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We protect our proprietary technology through a combination of patents, trade secrets and confidentiality agreements.

During the development of our products, our founder, President, Chief Executive Officer, and Chairman of the Board of Directors, Roger Susi, obtained a number of patents regarding our MRI compatible IV infusion pump and related systems.

During the development of our products, our founder, President, Chief Executive Officer, and Chairman of the Board, Roger Susi, obtained a number of patents regarding our MRI compatible IV infusion pump and related systems.

Susi has irrevocably assigned these patents to us.

We have 16 issued U.S.

patents and 4 issued foreign patents with remaining lives that range from 1 to 17 years.

patents and 4 issued foreign patents with remaining lives of up to 17 years.

We also have a number of U.S.

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These patents and patent applications relate to several of our products, including our MRI compatible IV infusion pump system and its components and our MRI compatible patient vital signs monitoring system.

We intend to file patent applications with respect to future patentable developments and improvements when we believe that such protection is in our best interest.

We intend to file patent applications with respect to future patentable developments and improvements when we believe that seeking such protection is in our best interest.

We also rely on trade secrets, copyright and other laws and on confidentiality agreements to protect our technology, but we believe that neither our patents nor other legal rights will necessarily prevent third parties from developing or using similar or related technology to compete against our products.

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Percent of Revenue

Years Ended December 31,

Year Ended December 31,

United States

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Percent of Revenue

Years Ended December 31,

Year Ended December 31,

Disposable, service and other

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We communicate with our customers on a regular basis to understand potential issues or concerns as well as to improve our products and services in response to their needs.

Product orders and inquiries are handled by trained service representatives who communicate with customers after equipment shipments, installations, and service repair calls.

Product orders and inquiries are handled by trained service representatives who communicate with customers after equipment shipments, installations, and service repair

We have implemented various other programs which enable us to assess our customers’ needs.

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We have never encountered a significant supply interruption from any sole supplier;

however, the operations of our third-party suppliers could be disrupted by conditions unrelated to our business operations or that are beyond our control, including but not limited to the global supply chain issues, international trade restrictions, excessive demand creating

shortages of available supply, and conditions related to health pandemics.

We continuously monitor our supply chain regarding these matters.

We continuously monitor our supply chain regarding these matters to anticipate and prevent risk of disruption.

We typically maintain no less than a three-month supply of raw materials and parts that are sourced from sole suppliers and make efforts to identify additional suppliers who may be able to provide such raw materials or parts.

For example, the non-magnetic, ultrasonic motor which drives our MRI compatible IV infusion pump is sole sourced from a major multinational Japanese manufacturing company with whom we have an excellent long-term relationship.

This company has exclusively provided us with these motors since 2005.

Our exclusive supply agreement with this company expired February 25, 2024.

This supply agreement was renewed March 2024, and extends through March 1, 2029.

For example, the non-magnetic, ultrasonic motor which drives our MRI compatible IV infusion pump was sole sourced from a major multinational Japanese manufacturing company until December 2024 when the Company in its ordinary course of business entered into a technology transfer and license agreement with the supplier allowing the Company to manufacture its own non-magnetic, ultrasonic motors.

We place significant emphasis on providing quality products and services to our customers.

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From time to time, we may determine that products manufactured or marketed by us do not meet our specifications, published standards or regulatory requirements.

When a quality issue is identified, we investigate the issue and seek to take appropriate corrective action, such as withdrawal of the product from the market, correction of the product at the customer location, notice to the customer of revised labeling or a combination of these or other corrective actions.

When a quality issue is identified, we investigate the issue and take appropriate corrective action, such as withdrawal of the product from the market, correction of the product at the customer location, notice to the customer of revised labeling or a combination of these or other corrective actions.

In January 2007, we received ISO 13485 certification and met the requirements under the European Medical Device Directive to use the CE Mark, thereby allowing us to continue to market our products in the European Community.

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These certificates will need renewal again by January 2028.

The medical products industry is generally characterized by intense competition and innovation via extensive research and new product development efforts.

The medical products industry is characterized by intense competition and innovation via extensive research and new product development efforts.

The market for medical products is subject to rapid change due to a competitive, cost-conscious environment and to government programs intended to reduce the cost of medical care.

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Historically, our only direct competitor in the MRI compatible IV infusion pump market, Bayer Radiology, formerly MEDRAD, Inc., announced during 2013 its decision to remove its competing Continuum pump system from the market, and discontinued support throughout the world in June 2015 due to ongoing regulatory issues.

As a result, we believe

that our MRidium 3860+ MRI compatible IV infusion pump is the only true MRI compatible IV infusion pump available today.

As a result, we believe that our MRidium 3860+ MRI compatible IV infusion pump is the only true MRI compatible IV infusion pump available today.

The medical device and IV infusion market is highly regulated and is typically one of the areas that the FDA scrutinizes closely for new market introductions.

Because of this, the FDA 510(k) clearance process for new infusion pumps is usually long and requires significant testing and documentation.

This long development timeline coupled with the low market penetration to date may discourage new competitors from undertaking a complex project like building an MRI compatible IV infusion pump.

This long timeline coupled with the low market penetration to date may discourage new competitors from undertaking a complex project like building an MRI compatible IV infusion pump.

We believe that the market for MRI compatible IV infusion pump products is underpenetrated and may become highly competitive if, and when, the market develops further.

We also compete with manufacturers of “shielded box” solutions that are intended to permit use of conventional IV pumps inside the MRI scanner room.

We also compete with manufacturers of “shielded box” solutions that are intended as “workarounds” to permit use of conventional IV pumps inside the MRI scanner room.

The providers of shielded boxes include B.

Braun, Fresenius Kabi and MIPM Mammendorfer Institut für Physik und Medizin.

Many of our potential customers opt not to purchase our MRI compatible IV infusion pump systems and instead use makeshift workarounds, such as placing conventional IV infusion devices outside of the MRI scanning room and utilizing extension tubing to reach the patient.

To this extent, we are in competition with conventional IV infusion pump manufacturers and distributors.

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There are several manufacturers that have developed competing MRI compatible vital signs monitoring systems that are currently on the market.

We believe the dominant competitor with a market-leading position in MRI compatible vital signs monitoring is Invivo Research, Inc., which was founded by Roger Susi, our founder, President, Chief Executive Officer, and Chairman of the Board of Directors.

Invivo is now owned by Koninklijke Philips NV (NYSE:

Other large and well-known companies such as GE Healthcare Technologies (NYSE:

We believe the dominant competitor with a market-leading position in MRI compatible vital signs monitoring is Invivo Research, which was founded by Roger Susi, our founder, President, Chief Executive Officer, and Chairman of the Board.

Invivo Research is now owned by Koninklijke Philips NV (NYSE:

Other large and well-known companies such as GE Healthcare Technologies (Nasdaq:

GEHC) and Schiller AG, also have competing products as do other smaller privately held companies.

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Our business operates as one reportable segment.

Financial information about geographic areas is presented in Notes 2 and 4 in the Notes to Financial Statements of this Annual Report on Form 10-K.

Financial information about geographic areas is presented in Notes 2 and 4 in the Notes to Financial Statements of this Annual Report.

Research and Development

Our research and development efforts focus on developing innovative products by utilizing our established core competencies in MRI compatible technologies and feedback from strategic relationships with hospitals, acute medical facilities and medical equipment manufacturers for new product ideas.

Our research and development efforts are driven by the leadership of our founder, Roger Susi, along with engineers and technical professionals with significant experience in systems engineering and product design.

Our research and development expenses were $2.9 million or 4.4 percent of revenue in 2023 and $2.3 million or 4.3 percent of revenue in 2022.

Our research and development efforts are driven by the leadership of our founder, President, Chief Executive Officer, and Chairman of the Board, Roger Susi, along with engineers and technical professionals with significant experience in systems engineering and product design.

Our research and development expenses remain consistent at $2.8 million or 3.9 percent of revenue in 2024 and $2.9 million or 4.4 percent of revenue in 2023.

Human Capital

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We have not experienced any work stoppages and consider our relations with our employees to be good.

We endeavor to maintain a workplace that is free from discrimination or harassment on the basis of color, race, sex, national origin, ethnicity, religion, age, disability, sexual orientation, gender identification or expression or any other status protected by applicable law.

We conduct annual training to reduce risks of harassment and discrimination and monitor employee conduct year-round, including by providing employees with access to an anonymous whistleblower hotline to report any allegations.

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Unless an exemption applies, each medical device that we market must first receive either premarket notification clearance (by making what is commonly called “a 510(k) submission”) or premarket approval (by filing a premarket approval application (“PMA”) from the FDA pursuant to the FDC Act).

In addition, certain modifications

made to marketed devices also may require 510(k) clearance or approval of a PMA supplement.

In addition, certain modifications made to marketed devices also may require 510(k) clearance or approval of a PMA supplement.

The FDA’s 510(k) clearance process varies in length and can extend beyond twelve months.

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were originally cleared through the 510(k) process as required by the FDA.

We cannot be sure that future medical devices or modifications of current medical devices, will qualify for the 510(k) pathway or whether 510(k) clearance or PMA approval will be obtained for any future product that we propose to market.

Our FMD1 is an example of this as a non-regulated product without diagnostic or therapeutic claims.

We cannot be sure that future medical devices or modifications of current medical devices will qualify for the 510(k) pathway or whether PMA approval will be required for any future product that we propose to market.

An exception is our FMD1, which does not fall under FDA regulation as it does not meet the definition of a medical device per section 201 (h) of the Food, Drug, and Cosmetic Act.

In December 2014, the FDA issued guidance entitled “Infusion Pumps Total Product Life Cycle.” This guidance established substantial additional pre-market requirements for new and modified infusion pumps.

Through this guidance, the FDA indicated more data demonstrating product safety will be required for future 510(k) submissions for infusion pumps, including the potential for more clinical and human factors data.

Through this guidance, the FDA required more data needed to demonstrate product safety for future 510(k) submissions for infusion pumps, including the potential for more clinical and human factors data.

The impact of this guidance is likely to result in a more time consuming and costly process to obtain regulatory clearance to market infusion pumps.

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The Anti-kickback Statute provides several exceptions or “safe harbors” for particular types of transactions.

While we generally do not file claims for reimbursement from government payers, the U.S.

While we do not file claims for reimbursement from government payers, the U.S.

federal government has asserted theories of liability against manufacturers under the Federal False Claims Act, which prohibits the submission of false claims to Medicare, Medicaid, and other state and federal programs.

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EFTA includes Iceland, Norway, Principality of Liechtenstein and Switzerland.

In May 2017, the European Union (the “EU”) implemented a new regulatory scheme for medical devices under the Medical Device Regulation (“MDR”).

In May 2017, the EU implemented a new regulatory scheme for medical devices under the Medical Device Regulation (“MDR”).

The MDR initially became effective in May 2021, however the MDR transition was recently extended to 2028 for Class IIb non-implanted devices.

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For example, several states and the District of Columbia either require the tracking and reporting of specific types of interactions with healthcare professionals or restrict such interactions.

A similar requirement was imposed at the federal level under the “sunshine” provision of Patient Protection and Affordable Care Act, (the “Sunshine Provisions”), to track and report payments and “transfers of value” to U.S.

A similar requirement was imposed at the federal level under the “sunshine” provision of Patient Protection and Affordable Care Act, to track and report payments and “transfers of value” to U.S.

physicians or teaching hospitals by manufacturers of medical products that are available for reimbursement by a federal insurer.

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Our telephone number is (407) 677-8022, and our website address is https://www.iradimed.com.

Information contained on, or accessible through, our website is provided for textual reference only and does not constitute part of, and is not

incorporated by reference into, this Annual Report.

Our common stock is listed and traded on Nasdaq under the symbol “IRMD”.

Information contained on, or accessible through, our website is provided for textual reference only and does not constitute part of, and is not incorporated by reference into, this Annual Report.

Our common stock is listed and traded on the Nasdaq Global Market (“Nasdaq”) under the symbol “IRMD”.

We make our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports, available free of charge in the “Investors” section of our website as soon as reasonably practicable after we file these reports with the SEC.

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A current copy of the Code of Ethics is posted on the Governance section of the Investors page of our website, which is located at www.iradimed.com.

We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding any substantive amendment to, or waiver from, a provision of the Code of Ethics by posting such information on our website address at https://www.iradimed.com.

We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding any

substantive amendment to, or waiver from, a provision of the Code of Ethics by posting such information on our website address at https://www.iradimed.com.

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.

What changed 10-K

Item 1. Business