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Item 1. Business

2025-06-20 compared with 2024-06-20 · 85 added, 76 removed, 261 unchanged (38% of the section changed)

Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company.

Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company.

Medtronic was founded in 1949 and today serves healthcare systems, physicians, clinicians, and patients in more than 150 countries worldwide.

We remain committed to a mission written by our founder in 1960 that directs us “to contribute to human welfare by the application of biomedical engineering in the research, design, manufacture, and sale of products to alleviate pain, restore health, and extend life.”

Our Mission — to alleviate pain, restore health, and extend life — empowers insight-driven care and better outcomes for our world.

We remain committed to being recognized as a company of dedication, honesty, integrity, and service.

Building on this strong foundation, we are embracing our role as a healthcare technology leader and evolving our business strategy in four key areas:

• Leveraging our pipeline to accelerate revenue growth:

The combination of our end markets, recent product launches and robust pipeline is expected to continue accelerating our growth over both the near-and long-term.

Our Mission — to alleviate pain, restore health, and extend life — empowers us to engineer the extraordinary and deliver better outcomes for our world.

We are a company of dedication, honesty, integrity, and service.

Building on this strong foundation, we are embracing our role as a healthcare technology leader and evolving our business strategy in three key areas:

• Accelerate innovation-driven growth:

The combination of our attractive end markets, recent product launches and robust pipeline is expected to enable continued strong revenue growth.

We aim to bring inventive and disruptive technology to large healthcare opportunities which enables us to better meet patient needs.

Patients around the world deserve access to our life-saving products, and we are driven to use our local presence and scale to increase the adoption of our products and services in markets around the globe.

• Serving more patients by accelerating innovation driven growth and delivering shareholder value:

• Deliver superior outcomes and better experiences for patients and providers:

We listen to our patients and customers to better understand the challenges they face.

From the patient journey, to creating agile partnerships that produce novel solutions, to making it easier for our customers to deploy our therapies — what we do is anchored in deep insight, and creates simpler, superior experiences.

• Creating and disrupting markets with our technology:

We are confident in our ability to maximize new technology, artificial intelligence (AI), and data and analytics to tailor therapies in real-time, facilitating remote monitoring and care delivery that conveniently manages conditions, and creates new standards of care.

• Empowering our operating units to be more nimble and more competitive:

Our operating model is organized to accelerate decision making, improve commercial execution, and more effectively leverage the scale of our company.

• Turn data, artificial intelligence (AI), and automation into action:

We are confident in our ability to maximize new technology, AI, and data and analytics to tailor therapies in real-time, facilitating remote monitoring and care delivery that conveniently manages conditions, and creates new standards of care.

We have four reportable segments that primarily develop, manufacture, distribute, and sell device-based medical therapies and services:

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Financial Statements and Supplementary Data" in this Annual Report on Form 10-K.

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CARDIOVASCULAR PORTFOLIO

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Principal products and services offered include:

• Implantable cardiac pacemakers including the Azure MRI SureScan, Adapta, Advisa MRI SureScan, and the Micra transcatheter pacing system.

• Implantable cardiac pacemakers including the Azure MRI SureScan, Adapta, Attesta MRI SureScan, and the Micra transcatheter pacing system.

Azure pacemakers feature Medtronic-exclusive BlueSync technology, which enables automatic, secure wireless remote monitoring with increased device longevity.

The 3830 lead, previously labeled for His-bundle pacing, has now been expanded to include left bundle branch area pacing effectively covering all current forms of conduction system pacing.

The 3830 lead, with His-bundle and left bundle branch capabilities, effectively covers all current forms of conduction system pacing and sensing.

The Micra transcatheter pacing system, which is leadless and does not have a subcutaneous device pocket like a conventional pacemaker, includes the Micra VR and the Micra AV device families.

Both of these pacemakers treat patients with atrioventricular block.

Both pacemakers treat patients with atrioventricular block.

• Implantable cardioverter defibrillators (ICDs), including the Aurora Extravascular-ICD, Visia AF MRI SureScan, Evera MRI SureScan, Primo MRI, and the Cobalt and Crome family of BlueSync-enabled ICDs, as well as defibrillator leads, including the Sprint Quattro Secure lead.

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• Cardiac ablation products include a full suite of electrophysiology solutions to treat patients with arrhythmias, including paroxysmal and persistent AF.

The portfolio includes the PulseSelect Pulsed Field Ablation System, Arctic Front Advanced Cardiac Cryoablation System, the DiamondTemp Ablation system, Sphere 9 catheter, the first of its kind with high density mapping capabilities combined with radio frequency and pulsed field energies to deliver ablation lesions, and Affera Mapping and Navigation System with Prism-1 software aimed at integrating clinical information to improve patient outcomes.

The portfolio includes the Arctic Front Advanced Cardiac Cryoblation System, PulseSelect single shot Pulsed Field Ablation catheter, the Sphere-9 focal catheter, providing high density mapping capabilities combined with dual radio frequency and pulsed field energies to deliver ablation lesions, and Affera Mapping and Navigation System with Prism-1 software aimed at integrating clinical information to improve patient outcomes.

• Insertable cardiac monitoring systems, including the Reveal LINQ and LINQ II.

These devices are for patients who experience transient symptoms such as dizziness, palpitation, syncope (fainting) and chest pain, as well as Cryptogenic Stroke patients;

which may indicate a cardiac arrhythmia that requires long-term monitoring or ongoing management.

These devices are for patients who experience transient symptoms such as dizziness, palpitation, syncope (fainting) and chest pain, as well as Cryptogenic Stroke patients, which may indicate a cardiac arrhythmia that requires long-term monitoring or ongoing management.

Both portfolio devices have unmatched accuracy and a streamlined workflow with AccuRhythm AI algorithms to reduce clinic workload and data burden.

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We continue a support program for patients with HVAD devices, and for caregivers and healthcare professionals who participate in their care.

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Structural Heart & Aortic

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The division includes therapies to treat heart valve disorders and aortic disease.

Our devices include products for the repair and replacement of heart valves, perfusion systems, positioning and stabilization systems for beating heart revascularization surgery, surgical ablation products, and comprehensive line of products and therapies to treat aortic disease, such as aneurysms, dissections, and transections.

Our devices include products for the repair and replacement of heart valves, perfusion systems, positioning and stabilization systems for beating heart revascularization surgery, surgical ablation products, and a comprehensive line of products and therapies to treat aortic disease, such as aneurysms, dissections, and transections.

Principal products offered include:

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The primary medical specialists who use the products of this group include spinal surgeons, neurosurgeons, neurologists, pain management specialists, anesthesiologists, orthopedic surgeons, urologists, urogynecologists, interventional radiologists, and ear, nose, and throat specialists.

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Cranial & Spinal Technologies

Our Cranial & Spinal Technologies division and Operating Unit develops, manufactures, and markets an integrated portfolio of devices and therapies for surgical technologies designed to improve the precision and workflow of neuro procedures, and a comprehensive line of medical devices and implants used in the treatment of the spine and musculoskeletal system.

Our Cranial & Spinal Technologies division and Operating Unit develops, manufactures, and markets an integrated portfolio of devices and therapies for surgical technologies designed to improve the precision and workflow of neurological procedures, and a comprehensive line of medical devices and implants used in the treatment of the spine and musculoskeletal system.

The division also provides biologic solutions for the orthopedic markets and offers unique and highly differentiated imaging, navigation, power instruments, and robotic guidance systems used in spine and cranial procedures.

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• Neurosurgery products, including platform technologies, implant therapies, and advanced energy products through the AiBLE spine technology ecosystem.

This includes our StealthStation S8 surgical navigation system, Stealth Autoguide cranial robotic guidance platform, O-arm Imaging System, Mazor X robotic guidance systems used in robot-assisted spine procedures, UNiD adaptive spine intelligence AI-driven technology for surgical planning and personalized spinal implants, and our Midas Rex surgical drills, including our MR8 high-speed drill system.

This includes our StealthStation S8 surgical navigation system, Stealth Autoguide cranial robotic guidance platform, O-arm Imaging System, Mazor robotic guidance systems used in robot-assisted spine procedures, UNiD adaptive spine intelligence AI-driven technology for surgical planning and personalized spinal implants, and our Midas Rex surgical drills, including our MR8 high-speed drill system.

• Products to treat a variety of conditions affecting the spine, including degenerative disc disease, spinal deformity, spinal tumors, fractures of the spine, and stenosis.

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Products also include the Pipeline Flex and Pipeline Vantage embolization devices with Shield Technology, endovascular treatments for large or giant wide-necked brain aneurysms, the portfolio of Solitaire revascularization devices for treatment of acute ischemic stroke, the Riptide aspiration system, the Onyx Liquid Embolic System, and a portfolio of associated access catheters including our React aspiration catheters also for the treatment of acute ischemic stroke.

• ENT products, including the Straightshot M5 microdebrider handpiece, the Integrated Power Console (IPC) system, NIM Vital nerve monitoring systems, Propel and Sinuva Sinus Implants from the acquisition of Intersect ENT, StealthStation ENT and StealthStation FlexENT navigation systems, as well as products for hearing restoration.

• ENT products, including the Straightshot M5 microdebrider handpiece, the Integrated Power Console (IPC) system, NIM Vital nerve monitoring systems, Propel and Sinuva Sinus Implants, StealthStation ENT and StealthStation FlexENT navigation systems, as well as products for hearing restoration.

• Pelvic health products, including our InterStim X and InterStim II recharge-free neurostimulators, InterStim Micro rechargeable neurostimulators, and SureScan MRI leads.

Our NURO System delivers Percutaneous Tibial Neuromodulation therapy to treat overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

Our NURO System delivers Percutaneous Tibial Neuromodulation therapy to treat overactive bladder, (non-obtrusive) urinary retention, and chronic fecal incontinence.

Neuromodulation

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• Spinal cord stimulation products, including rechargeable and recharge-free devices and a large selection of leads used to treat chronic back and/or limb pain and chronic pain resulting from diabetic peripheral neuropathy.

This includes the Intellis (rechargeable) and Vanta (recharge-free) spinal cord stimulation systems, with AdaptiveStim and SureScan MRI Technology, DTM (differential target multiplexed) proprietary waveform, the Evolve workflow algorithm, and Snapshot reporting, as well as the Inceptiv spinal cord stimulation system, which offers a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time.

• Brain modulation products, including those for the treatment of the disabling symptoms of Parkinson's disease, essential tremor, refractory epilepsy, severe, treatment-resistant obsessive-compulsive disorder (approved under a Humanitarian Device Exemption (HDE) in the U.S.), and chronic, intractable primary dystonia (approved under a HDE in the U.S.).

Specifically, this includes our family of Activa neurostimulators, including Activa SC (single-channel primary cell battery), Activa PC (dual channel primary cell battery), and Activa RC (dual channel rechargeable battery), as well as our family of Percept neurostimulators, the Percept PC, Percept RC, and our SenSight directional lead system with the proprietary BrainSense technology.

• Implantable drug infusion systems, including our SynchroMed III Implantable Infusion System, that deliver small quantities of drug directly into the intrathecal space surrounding the spinal cord.

• Interventional products, including the Kyphon Balloon, the Kyphon V Premium, and Kyphon Assist systems and the OsteoCool RF Tumor ablation system.

• The Accurian nerve ablation system, which conducts radio frequency ablation of nerve tissues.

This includes the Inceptiv spinal cord stimulation system which offers a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time, Intellis (rechargeable) and Vanta (recharge-free) spinal cord stimulation systems, with

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AdaptiveStim and SureScan MRI Technology, DTM (differential target multiplexed) proprietary waveform, and the Evolve workflow algorithm, and Snapshot reporting.

• Brain modulation products, including those for the treatment of Parkinson's disease, essential tremor, refractory epilepsy, severe, treatment-resistant obsessive-compulsive disorder (approved under a Humanitarian Device Exemption (HDE) in the U.S.), and chronic, intractable primary dystonia (approved under a HDE in the U.S.).

Specifically, the Percept family of neurostimulators with proprietary adaptive BrainSense technology.

• Implantable drug infusion systems, including our SynchroMed III Implantable Infusion System, which deliver small quantities of drug directly into the intrathecal space surrounding the spinal cord, to help manage chronic pain, cancer pain, and severe spasticity.

• Interventional products, including our full Kyphon portfolio of minimally invasive Kyphoplasty and Vertebroplasty solutions for the treatment of vertebral compression fractures, including bipedicular and unipedicular access options, bone access tools, inflatable balloon tamps, cement and delivery systems, as well as biopsy and specialty devices.

The OsteoCool cooled radiofrequency ablation system with simultaneous, dual-probe capabilities and algorithms for the treatment of painful metastatic bone lesions.

Emprint Microwave with Thermosphere technology for the treatment of non-resectable liver tumors.

As well as the Accurian nerve ablation system, which conducts radio frequency ablation of nerve tissues.

MEDICAL SURGICAL PORTFOLIO

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Surgical and Endoscopy.

The division develops, manufactures, and markets advanced and general surgical products, including advanced stapling devices, vessel sealing instruments, wound closure products, electrosurgery products, AI-powered surgical video and analytics platform, and robotic-assisted surgery products, hernia mechanical devices, mesh implants, gynecology products, minimally invasive gastrointestinal and hepatologic diagnostics and therapies, and therapies to treat diseases and conditions that are typically, but not exclusively, addressed by surgeons.

The division develops, manufactures, and markets advanced and general surgical products, including advanced stapling devices, vessel sealing instruments, wound closure products, electrosurgery products, AI-powered surgical video and analytics platform, robotic-assisted surgery products, hernia mechanical devices, mesh implants, gynecology products, minimally invasive gastrointestinal and hepatologic diagnostics and therapies, and therapies to treat diseases and conditions that are typically, but not exclusively, addressed by surgeons.

Principal products and services offered include:

• Advanced stapling and energy products, including the Tri-Staple technology platform for endoscopic stapling, including the Endo GIA reloads and reinforced reloads with Tri-Staple technology and the Endo GIA ultra universal stapler, the Signia powered stapling system, the LigaSure exact dissector and L-Hook Laparoscopic Sealer/Divider, and the Sonicision 7 curved jaw cordless ultrasonic dissection system.

• Electrosurgical hardware and instruments, including the Valleylab FT10 energy platform, the Valleylab LS10 generator, and the Force TriVerse electrosurgical pencils.

• Electrosurgical hardware and instruments, including the Valleylab FT10 and FX8 energy platforms, the Valleylab FT10 vessel sealing generator, and the Force TriVerse electrosurgical pencils.

• Robotic and digital surgery technologies, including the Hugo robotic-assisted surgery (RAS) system designed for a broad range of soft-tissue procedures, and Touch Surgery Enterprise, an AI-powered surgical video management solution for the operating room.

• Products designed for the treatment of hernias, including the AbsorbaTack absorbable mesh fixation device for hernia repair, the Symbotex composite mesh for surgical laparoscopic and open ventral hernia repair, and ProGrip laparoscopic self-fixating mesh, a self-gripping, biocompatible solution for inguinal hernias.

• Products designed for the treatment of hernias, including the AbsorbaTack absorbable mesh fixation device for hernia repair, MaxTack motorized fixation device designed for minimally invasive hernia fixation, the Symbotex composite mesh for surgical laparoscopic and open ventral hernia repair, and ProGrip laparoscopic self-fixating mesh, a self-gripping, biocompatible solution for inguinal hernias.

• Suture and wound closure products, including the V-Loc barbed sutures, the Polysorb braided absorbable sutures, and the Monosof absorbable monofilament nylon sutures.

• Endoscopy products, including the GI Genius intelligent endoscopy module, the PillCam capsule endoscopy systems, the Bravo calibration-free reflux testing systems, the Endoflip Impedance Planimetry System, the Emprint ablation system with Thermosphere Technology, the ManoScan Bravo system, the Barrx platform through ablation with the Barrx 360 Express catheter, the Cool-tip radiofrequency ablation system, the HET bipolar system, the Beacon delivery system, and the Nexpowder endoscopic hemostasis system.

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• Endoscopy products, including the GI Genius intelligent endoscopy module, the PillCam capsule endoscopy systems, the Bravo calibration-free reflux testing systems, the Endoflip 300 Impedance Planimetry System, the Emprint ablation system with Thermosphere Technology, the ManoScan high-resolution manometry system, the Barrx platform through ablation with the Barrx 360 Express catheter, the Cool-tip radiofrequency ablation system, the Beacon delivery system, and the Nexpowder endoscopic hemostasis system.

Acute Care & Monitoring

Our Acute Care & Monitoring division develops, manufactures, and markets products in the fields of patient monitoring and airway management.

In February 2024, the Company announced the decision to exit its ventilator product line and combine the remaining Patient Monitoring & Respiratory Interventions businesses into one business unit called Acute Care & Monitoring.

Principal products and services offered include:

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The MiniMed 780G system provides smartphone and Bluetooth connectivity, a meal-time detection system, an adjustable glucose target down to 100 mg/dl, and has the capability to continuously deliver background insulin and monitor sugar levels.

• Continuous glucose monitoring (CGM) system, the Guardian Connect CGM system, which is worn by patients capturing glucose data to reveal patterns and potential problems, such as hyperglycemic and hypoglycemic episodes.

• Continuous glucose monitoring (CGM) systems include the Guardian Connect CGM system and Simplera platform.

Both systems are worn by patients capturing glucose data to reveal patterns and potential problems, such as hyperglycemic and hypoglycemic episodes.

The Simplera platform's discreet design simplifies the insertion and wear experience through the integration of the Simplera CGM, as a Smart Multiple Daily Injections (MDI) system, and the InPen with the Simplera Sync sensor and the MiniMed 780G system, offering disposable capabilities.

• The InPen smart insulin pen system combines a reusable Bluetooth-enabled insulin pen with an intuitive mobile app that helps users administer the appropriate insulin dose.

The InPen application integrates with our CGM data to provide real-time CGM readings alongside insulin dose information.

In May 2025, we announced our intention to separate the Diabetes business, with the intention to create a new independent, publicly traded company.

The separation is expected to be completed within 18 months of the initial announcement.

HUMAN CAPITAL

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We aspire to create an inclusive, diverse, and equitable workplace that fosters innovation and creativity, and where employees feel a sense of belonging and well-being.

Medtronic has 95,000+ full-time employees, of which 44% are based in the U.S.

Medtronic has over 95,000 full-time employees, of which 44% are based in the U.S.

or Puerto Rico.

Inclusion, Diversity & Equity

We believe that improving health for people from all walks of life depends on our ability to unleash the creative power of our diverse global employees.

By breaking down barriers to Inclusion, Diversity and Equity (ID&E), we open doors for everyone, driving progress and prosperity around the world.

We integrate ID&E principles throughout our Company to ensure every operating unit, team, and leader recognizes and celebrates the value of diverse experiences and backgrounds.

As of the end of fiscal year 2024, 41% of our U.S.

workforce is ethnically diverse;

women comprise 51% of our global workforce;

44% of our manager and above employees are women;

and 28% of our U.S.

managers are ethnically diverse.

Additionally, Medtronic employee resource groups (ERGs) are employee-led affinity groups that provide career development and networking opportunities for members and strengthen ties between employees of many different backgrounds, cultures, and interests.

In fiscal year 2024, there were 13 ERGs and Diversity Networks across 300+ hubs or chapters in over 65 countries with more than 35,000 employees involved.

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We believe that improving health for people from all walks of life depends on our ability to unleash the creative power of our global employees.

By breaking down barriers, we open doors for everyone, driving opportunity, progress, and prosperity around the world.

Our commitment to inclusion is a core element of the Medtronic Mission, and we integrate these principles throughout our Company to ensure every operating unit, team, and leader recognizes and celebrates the value of diverse experiences and backgrounds.

Additionally, Medtronic employee resource groups (ERGs) and Networks are employee-led affinity groups that provide career development and networking opportunities to all employees and strengthen ties between employees of many different backgrounds, cultures, and interests.

In our most recent reported period available, in the United States, we have achieved 100% pay equity for gender and ethnically diverse employees.

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Workforce Compensation

Our compensation framework is designed to celebrate the value and contributions of our employees.

Our compensation framework is designed to provide market competitive pay for the value and contributions of our employees.

We are committed to transparent communications on compensation.

Our competitive approach to compensation reflects industry benchmarks and local market standards.

programs include annual and long-term equity-based incentives that provide the means to share in the Company’s success, based on business and individual performance.

Our programs include annual and long-term equity-based incentives that provide the means to share in the Company’s success, based on business and individual performance.

To attract and retain the best leaders, we offer competitive benefits and cash and equity incentives.

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and Puerto Rico employees can now participate through MAPS (Medtronic Advancement Pathways and Skill-building) in undergraduate courses from top-tier universities to enhance or obtain new skills, at no cost to the employee.

Our change in approach has opened opportunities for employees who have been otherwise restricted from career advancement due to degree requirements.

We have opened opportunities for employees who have been otherwise restricted from career advancement due to degree requirements.

Employee Engagement and Culture

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Medtronic carefully reviews and implements actions based on employee feedback in order to partner and create an inclusive, innovative and supportive environment.

Our culture, how we show up and get things done, is critical to achieving our vision.

Our culture is critical to achieving our vision.

The Medtronic Mindset builds on our core values of integrity, quality, inclusion, and collaboration.

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The Medtronic Employee Emergency Assistance Fund is supported by donations from employees and the Medtronic Foundation, and over the last five years has provided $4 million in grants to employees experiencing unexpected events creating a financial hardship.

For more information on Human Capital Management at Medtronic, please refer to our 2023 Sustainability Report as well as Medtronic’s 2023 Global Inclusion, Diversity and Equity Report available on our company website.

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For more information on Human Capital Management at Medtronic, please refer to our 2024 Impact Report available on our company website.

OTHER FACTORS IMPACTING OUR OPERATIONS

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Our R&D activities include improving existing products and therapies, expanding their indications and applications for use, developing new therapies and procedures, and entering into arrangements with third parties to fund the development of certain technologies.

We continue to focus on optimizing innovation, improving our R&D productivity, driving growth in emerging markets, generating clinical evidence, and

assessing our R&D programs based on their ability to address unmet clinical needs, produce better patient outcomes, and create new standards of care.

We continue to focus on optimizing innovation, improving our R&D productivity, driving growth in international markets, generating clinical evidence, and assessing our R&D programs based on their ability to address unmet clinical needs, produce better patient outcomes, and create new standards of care.

Intellectual Property and Litigation

We rely on a combination of patents, trademarks, tradenames, copyrights, trade secrets, and agreements, including non-disclosure agreements, to protect our business and proprietary technology.

In addition, we have entered into exclusive and non-exclusive licenses relating to a wide array of third-party technologies.

In the aggregate, these intellectual property assets and licenses are of material importance to our business;

however, we believe that no single intellectual property asset or license is material in relation to our business as a whole.

In addition, we have entered into exclusive and non-exclusive licenses, and covenants not to sue, relating to a wide array of third-party technologies.

In the aggregate, these intellectual property assets, agreements, and licenses are of material importance to our business;

however, we believe that no single intellectual property asset, agreement, or license is material in relation to our business as a whole.

We operate in an industry characterized by extensive intellectual property litigation.

Intellectual property litigation may result in significant damage awards and injunctions that could prevent the manufacture and sale of affected products or result in significant royalty payments in order to continue selling the products.

At any given time, we are generally involved as both a plaintiff and a defendant in a number of patent infringement actions, the outcomes of which may not be known for prolonged periods of time.

At any given time, we are generally involved as both a plaintiff and a defendant in a number of intellectual property actions, the outcomes of which may not be known for prolonged periods of time.

Sales and Distribution

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Additionally, a portion of the Company's revenue is generated from consignment inventory maintained at hospitals.

Our medical supply products are used primarily in hospitals, surgical centers, and alternate care facilities, such as home care and long-term care facilities, and are marketed to materials managers, group purchasing organizations (GPOs) and integrated delivery networks (IDNs).

Our medical supply products are used primarily in hospitals, ambulatory surgical centers, and alternate care facilities, such as home care and long-term care facilities, and are marketed to materials managers, group purchasing organizations (GPOs) and integrated delivery networks (IDNs).

We often negotiate with GPOs and IDNs, which enter into supply contracts for the benefit of their member facilities.

Our four largest markets are the U.S., Western Europe, China, and Japan.

Emerging markets are an area of increasing focus and opportunity, as we believe they remain under-penetrated.

International markets are an area of increasing focus and opportunity, as we believe they remain under-penetrated.

Our marketing and sales strategy is focused on rapid, cost-effective delivery of high-quality products to a diverse group of customers worldwide.

To achieve this objective, our marketing and sales teams are organized around physician specialties.

This focus enables us to develop highly knowledgeable and dedicated sales representatives who are able to foster strong relationships with physicians and other customers and enhance our ability to cross-sell complementary products.

We are not dependent on any single customer for more than 10 percent of our total net sales.

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Major shifts in industry market share have occurred in connection with product corrective actions, physician advisories, safety alerts, results of clinical trials to support superiority claims, and publications about our products, reflecting the importance of product quality, product efficacy and quality systems in the medical device industry.

In the current environment of managed care, economically motivated customers, consolidation among healthcare providers, increased competition, declining reimbursement rates, and national and provincial tender pricing, competitively priced product offerings are essential to our business.

In the current environment of managed care, economically motivated

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customers, consolidation among healthcare providers, increased competition, declining reimbursement rates, and national and provincial tender pricing, competitively priced product offerings are essential to our business.

In order to continue to compete effectively, we must continue to create or acquire advanced technology, incorporate this technology into proprietary products, obtain regulatory approvals in a timely manner, maintain high-quality manufacturing processes, and successfully market these products.

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Production and Availability of Raw Materials

We manufacture products at manufacturing facilities located in various countries throughout the world.

We manufacture products at facilities located in various countries throughout the world.

We purchase many of the components and raw materials used in manufacturing our products from numerous suppliers in various countries.

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To varying degrees, each of these agencies requires us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing, distribution, and post-marketing surveillance of our products.

Our business is also affected by patient and data privacy laws and government payor cost containment initiatives, as well as environmental health and safety laws and regulations.

In addition, as a result of the release and availability of Artificial Intelligence (AI) technologies, including generative AI platforms, we have seen a global trend toward more comprehensive and refined regulation of AI that will impact our business, such as the White House's Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence and the EU AI Act, that are designed to ensure the ethical use, security, and privacy of AI and create standards for transparency, accountability, and fairness.

Our business is also affected by data privacy, security and digital health laws, such as the European Health Data Space (EHDS) regulation, as well as government payor cost containment initiatives, and environmental health and safety laws and regulations.

In addition, as a result of the release and availability of Artificial Intelligence (AI) technologies, including generative AI platforms, we have seen a global trend toward more comprehensive regulation of AI designed to ensure the ethical use, security, and privacy of AI and create standards for transparency, accountability, and fairness, including the EU AI Act, which may impact our business.

Product Approval and Monitoring

In many countries where we do business, including the U.S., E.U.

countries, Japan, and China, our products are subjected to approval and other regulatory requirements regarding performance, safety, and quality.

In many jurisdictions where we do business, including the U.S., the E.U., Japan, and China, our products are subjected to approval and other regulatory requirements regarding performance, safety, and quality.

For instance, authorization to commercially distribute a new medical device in the U.S.

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The regulation provided an implementation period and became effective on May 26, 2021.

The European Commission recently extended the implementation period to the end of 2027 for high-risk devices and to the end of 2028 for medium and low risk devices.

The European Commission extended the implementation period to the end of 2027 for high-risk devices and to the end of 2028 for medium and low risk devices.

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The global regulatory environment is increasingly stringent and unpredictable.

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We expect this global regulatory environment will continue to evolve, which could impact the cost, the time needed to approve, and ultimately, our ability to maintain existing approvals or obtain future approvals for our products.

In addition, reported potential workforce reductions and agency reorganization at the U.S.

FDA, if implemented, could have an impact on product approval timelines.

Regulations of the U.S.

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Trade Regulations

The movement of products, services, technology, know-how, and investment across borders subjects us to extensive trade laws and regulations.

The movement of products, services, technology, know-how, and investment across borders subjects us to extensive trade laws and regulations, including tariff regulations adopted by different countries or trading zones.

These laws and regulations govern, among other things, our import, export and other international trade activities.

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Our business relies on the secure electronic transmission, storage and hosting of sensitive information, including personal information, protected health information, financial information, intellectual property and other sensitive information related to our products and therapies, customers, patients, and workforce.

Our global operational footprint comes with the obligation for compliance and adherence to individual data security, confidentiality and breach notification laws at the State Level, Federal Level, and International Level.

Examples of those laws include, in the U.S., the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and various State privacy laws that have become effective recently.

We are also subject to various other country-specific requirements around the world, such as the General Data Protection Regulation (GDPR) in the European Economic Area, the United Kingdom’s version of the same, and China's Personal Information Protection Law (PIPL).

Because the laws and regulations continue to expand, differ from jurisdiction to jurisdiction, and are subject to evolving (and at times inconsistent) governmental interpretation, compliance with these laws and regulations may require significant additional cost expenditures or changes in products or business that increase competition or reduce revenue.

We also are subject to various other country-specific requirements around the world, such as the General Data Protection Regulation (GDPR) in the European Economic Area, the United Kingdom’s privacy laws, and China's Personal Information Protection Law (PIPL).

Because the laws and regulations continue to expand, differ from jurisdiction to jurisdiction, and are subject to evolving (and at times inconsistent) governmental interpretation and different cross border data transfer rules, compliance may require significant additional cost expenditures or changes in products or business that increase competition or reduce revenue.

Noncompliance could result in the imposition of fines, penalties, or orders to stop noncompliant activities, withdrawal of noncompliant products from a market, and reputational harm.

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agencies responsible for reimbursement and regulation of healthcare items and services.

laws and regulations are imposed primarily in connection with federally funded healthcare programs, such as the Medicare and Medicaid programs, as well as the government’s interest in regulating the quality and cost of healthcare.

laws and regulations are imposed

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primarily in connection with federally funded healthcare programs, such as the Medicare and Medicaid programs, as well as the government’s interest in regulating the quality and cost of healthcare.

Other governments also impose regulations in connection with their healthcare reimbursement programs and the delivery of healthcare items and services.

In addition, reported potential workforce reductions and agency reorganization at HHS, if implemented, could have an impact on reimbursement programs.

federal healthcare laws apply when we or customers submit claims for items or services that are reimbursed under federally-funded healthcare programs, including laws related to kickbacks, false claims, self-referrals or other healthcare fraud.

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In addition, as a manufacturer of U.S.

FDA-approved devices reimbursable by federal healthcare programs, we are subject to the Physician Payments Sunshine Act, which requires us to annually report certain payments and other transfers of value we make to U.S.-licensed physicians or U.S.

FDA-approved devices reimbursable by federal healthcare programs, we are subject to the U.S.

Physician Payments Sunshine Act (Open Payments), which requires us to annually report certain payments and other transfers of value we make to U.S.-licensed physicians, certain allied health professionals, and U.S.

teaching hospitals.

8 unchanged sentences

Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (Exchange Act) are made available under the “Our Company – Investors” caption and “Financials – SEC Filings” sub caption of our website as soon as reasonably practicable after we electronically file them with, or furnish them to, the Securities and Exchange Commission (SEC).

Information relating to our corporate governance, including our Principles of Corporate Governance, Code of Conduct (including our Code of Ethics for Senior Financial Officers and any related amendments or waivers), Code of Business Conduct and Ethics for Members of the Board of Directors, and information concerning our executive officers, directors and Board committees (including committee charters) is available through our website at www.medtronic.com under the “Our Company – Governance” caption.

Information relating to our corporate governance, including our Principles of Corporate Governance, Code of Conduct (including our Code of Ethics for Senior Financial Officers and any related amendments or waivers), Code of Business Conduct and Ethics for Members of the Board of Directors, AI Compass, and information concerning our executive officers, directors and Board committees (including committee charters) is available through our website at www.medtronic.com under the “Our Company – Governance” caption.

Information relating to transactions in Medtronic securities by directors and officers is available through our website at www.medtronic.com under the “Our Company – Investors” caption and the “Financial Information – SEC Filings” sub caption.

4 unchanged sentences

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