What changed in this filing

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Item 1. Business

2026-06-18 compared with 2025-06-20 · 95 added, 82 removed, 264 unchanged (40% of the section changed)

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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.

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

• Turn data, 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:

the Cardiovascular Portfolio, the Neuroscience Portfolio, the Medical Surgical Portfolio, and the Diabetes Operating Unit.

For more information regarding our segments, please see Note 19 to the consolidated financial statements in "Item 8.

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

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

the Cardiovascular Portfolio, the Neuroscience Portfolio, and the Medical Surgical Portfolio.

In May 2025, the Company announced its intent to separate the Diabetes Business, with the intention to create a new independent, publicly traded company, MiniMed Group, Inc.

On March 9, 2026, MiniMed completed an initial public offering (the IPO).

As a result, during the fourth quarter of fiscal year 2026, the Diabetes Operating Unit was no longer considered a reportable segment.

For additional information regarding our segments, refer to the Business sections below and Note 19 to our consolidated financial statements in "Item 8.

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

Unless otherwise specified, the Company's business metrics presented in this report include our Diabetes Business.

Such metrics may not be directly comparable to future periods following any separation of our Diabetes Business.

Additionally, certain line items and metrics presented for the Diabetes Business in this report may not be directly comparable to those presented by our consolidated subsidiary, MiniMed, in its public filings.

Investors are encouraged to review MiniMed's filings with the SEC for information regarding MiniMed's business and results.

Any such filings are not incorporated by reference into this Annual Report on Form 10-K.

For additional information regarding the MiniMed separation, refer to Note 20 to our consolidated financial statements in "Item 8.

Financial Statements and Supplementary Data" of 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, Attesta MRI SureScan, and the Micra transcatheter pacing system.

• Implantable cardiac pacemakers including the Azure MRI SureScan, XT and S models, 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, with His-bundle and left bundle branch capabilities, effectively covers all current forms of conduction system pacing and sensing.

The SelectSecure 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 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.

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

• Implantable cardiac resynchronization therapy devices (CRT-Ds and CRT-Ps) including the Claria/Amplia/Compia family of MRI Quad CRT-D SureScan systems and the Cobalt and Crome portfolio of BlueSync-enabled CRT-Ds, as well as the Percepta/Serena/Solara family of MRI Quad CRT-P SureScan systems.

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

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.

The portfolio includes the PulseSelect and Affera Sphere-360 single shot pulsed field ablation catheters, the Affera Sphere-9 focal catheter, providing high density mapping capabilities combined with dual radio frequency and pulsed field energies to deliver ablation lesions, the Affera Mapping and Navigation System with Prism software aimed at integrating clinical information to improve patient outcomes, and the Arctic Front Advanced Cardiac Cryoablation System.

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

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LINQ II, the premium portfolio device, offers extended device longevity and remote programming capabilities.

• TYRX products, including the Cardiac and Neuro Absorbable Antibacterial Envelopes, which are designed to stabilize electronic implantable devices and help prevent infection associated with implantable pacemakers and defibrillators.

• TYRX, an absorbable antibacterial mesh envelope used during implantation of cardiac rhythm management and neuromodulation devices to stabilize devices and help prevent infection.

• Remote monitoring services and patient-centered software to enable efficient care coordination as well as services related to hospital operational efficiency.

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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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• CoreValve family of aortic valves, including the Evolut PRO, Evolut PRO+, Evolut FX, and Evolut FX+ TAVR systems for transcatheter aortic valve replacement.

• Surgical valve replacement and repair products for damaged or diseased heart valves, including both tissue and mechanical valves;

• Surgical valve replacement and repair products, including the Avalus Ultra surgical valve, for damaged or diseased heart valves, including both tissue and mechanical valves;

blood-handling products that form a circulatory support system to maintain and monitor blood circulation and coagulation status, oxygen supply, and body temperature during arrested heart surgery;

and surgical ablation systems and positioning and stabilization technologies.

• Endovascular stent grafts and accessories, including the Endurant II Stent Graft System for the treatment of abdominal aortic aneurysms, the Valiant Captivia Thoracic Stent Graft System for thoracic endovascular aortic repair procedures, and the Heli-FX EndoAnchor System.

• Endovascular stent grafts and accessories, including the Endurant II and Endurant IIs Stent Graft System for the treatment of abdominal aortic aneurysms, the Valiant Captivia Thoracic Stent Graft System for thoracic endovascular aortic repair procedures, and the Heli-FX EndoAnchor System.

• Transcatheter Pulmonary Valves, including Harmony Transcatheter Pulmonary Valve (TPV) and Delivery Catheter System and Melody TPV/Ensemble II Delivery System.

• Left atrial appendage exclusion systems to reduce the risk of stroke in patients with AF, including the Penditure LAA exclusion system.

• Extracorporeal Membrane Oxygenation (ECMO) systems to provide control of blood pumping through an extracorporeal circuit during ECMO procedures, including the VitalFlow ECMO system.

Coronary & Peripheral Vascular

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Principal products offered include:

• Percutaneous Coronary Intervention products including our Onyx Frontier and Resolute Onyx drug-eluting stents, Euphora balloons, and Launcher guide catheters.

• Percutaneous Coronary Intervention products including our Neuroguard IEP carotid stenting system, Onyx Frontier and Resolute Onyx drug-eluting stents (DES), Euphora balloons, and Launcher guide catheters.

• Products to treat hypertension including our Symplicity Spyral renal denervation (RDN) system.

• Percutaneous angioplasty balloons including the IN.PACT family of drug-coated balloons, vascular stents including the Abre venous stent, directional atherectomy products including the HawkOne directional atherectomy system, and other procedure support tools.

• Products to treat superficial venous diseases in the lower extremities including the ClosureFast radiofrequency ablation system and the VenaSeal Closure System.

• Endovenous products to treat superficial venous diseases in the lower extremities including the ClosureFast radiofrequency ablation (RFA) system and the VenaSeal closure system.

NEUROSCIENCE PORTFOLIO

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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

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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 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 robotic guidance system, O-arm surgical 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.

These products include our CATALYFT PL expandable interbody spacers, CD Horizon ModuLeX spinal system, and T2 STRATOSPHERE expandable corpectomy system.

These products include our Catalyft PL and PL40 expandable interbody spacers, CD Horizon ModuLeX spinal system, and T2 Stratosphere expandable corpectomy system.

These products can also include titanium interbody implants and surface technologies, such as our Adaptix interbody system and incorporated Titan interbody fusion device with nanoLOCK technology.

• Products that facilitate less invasive thoracolumbar surgeries, including the CD Horizon Solera Voyager percutaneous fixation system and various retractor systems to access the spine through smaller incisions.

• Products to treat conditions in the cervical region of the spine, including the ZEVO anterior cervical plate system, the Infinity Occipitocervical-Upper Thoracic (OCT) System, and Prestige LP cervical discs.

• Products to treat conditions in the cervical region of the spine, including the Zevo anterior cervical plate system, the Infinity Occipitocervical-Upper Thoracic (OCT) System, and the Prestige LP cervical disc.

• Biologic solutions products, including our Infuse bone graft (InductOs in the European Union (E.U.)), which contains a recombinant human bone morphogenetic protein-2, rhBMP-2, for certain spinal, trauma, and oral maxillofacial applications.

• Demineralized bone matrix products, including Magnifuse, GRAFTON/GRAFTON PLUS, and the Mastergraft family of synthetic bone graft products – Matrix, Putty, Strip, and Granules.

• Demineralized bone matrix (DBM) products, including Magnifuse, Grafton/Grafton Plus, and the Mastergraft family of synthetic bone graft products – Matrix, Putty, Strip, and Granules.

Specialty Therapies

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This includes coils, neurovascular stent retrievers, and flow diversion products, as well as access and delivery products to support procedures.

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.

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, including the Neuroguard IEP carotid stenting system.

• 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.

The Stealth AXiS surgical system integrates established navigation workflows with a modular robotic architecture.

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• 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, (non-obtrusive) urinary retention, and chronic fecal incontinence.

Our NURO System delivers Percutaneous Tibial Neuromodulation therapy to treat overactive bladder, (non-obtrusive) urinary retention, including the Altaviva system, 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 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.

This includes the Inceptiv spinal cord neurostimulation 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 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.

Specifically, the Percept family of neurostimulators with 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.

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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.

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

The Medical Surgical Portfolio includes the Surgical & Endoscopy and Acute Care & Monitoring divisions.

Products and therapies of this group are used primarily by healthcare systems, physicians' offices, ambulatory care centers, and other alternate site healthcare providers.

Products and therapies of this group are used primarily by healthcare systems, physicians' offices, ambulatory surgical centers (ASCs), and other alternate site healthcare providers.

While less frequent, some products and therapies are also used in home settings.

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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, 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, an 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 and FX8 energy platforms, the Valleylab FT10 vessel sealing generator, and the Force TriVerse electrosurgical pencils.

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• Electrosurgical hardware and instruments, including the Valleylab FT10 and FX8 energy platforms, LigaSure vessel-sealing instruments, Bipolar instruments, 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.

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

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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.

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

Principal products and services offered include:

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• Products focused on airway management and respiratory monitoring, including Microstream capnography monitors, McGRATH MAC video laryngoscopes, Shiley endotracheal tubes, Shiley tracheostomy tubes, and DAR Breathing Systems.

DIABETES OPERATING UNIT

The Diabetes Operating Unit develops, manufactures, and markets products and services for the management of Type 1 and Type 2 diabetes.

The all other businesses include the operations and ongoing transition agreements from businesses the Company has exited, divested, or intends to separate, such as the Diabetes Business.

The Diabetes Business develops, manufactures, and markets products and services for the management of Type 1 and Type 2 diabetes.

The primary medical specialists who use and/or prescribe our Diabetes products are endocrinologists and primary care physicians.

Principal products and services offered include:

• Insulin pumps and consumables, including the MiniMed 780G system, powered by SmartGuard technology.

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) 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.

The principal products and services offered by the Diabetes Business include insulin pumps, continuous glucose monitoring (CGM) systems, and consumables.

For additional information regarding the Diabetes Business separation, refer to Note 20 to our consolidated financial statements in "Item 8.

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

HUMAN CAPITAL

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or Puerto Rico.

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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.

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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.

Additionally, Medtronic employee resource groups (ERGs) and Diversity 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.

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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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1) Employee Engagement, 2) Inclusion, 3) Innovation, 4) Ethics and 5) Quality culture as part of our commitment to Put Patients First in our everyday decisions and actions.

In our most recent survey ending in the fourth quarter of fiscal year 2025, more than 88% of our employees responded.

In our most recent survey ending in the fourth quarter of fiscal year 2026, 87% of our employees responded.

This metric does not include our Diabetes Business.

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

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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 $3 million in grants to employees experiencing unexpected events creating a financial hardship.

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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.

For additional information on Human Capital Management at Medtronic, refer to our 2025 Impact Report available on our company website.

OTHER FACTORS IMPACTING OUR OPERATIONS

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Our research and development (R&D) efforts are directed toward maintaining or achieving technological leadership in the markets we serve to help ensure that patients using our devices and therapies receive the most advanced and effective treatment possible.

We remain committed to developing technological enhancements and new indications for existing products, and less invasive and new technologies for new and emerging markets to address unmet patient needs.

We remain committed to developing technological enhancements and

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new indications for existing products, and less invasive and new technologies for new and emerging markets to address unmet patient needs.

That commitment leads to our initiation and participation in hundreds of clinical trials each fiscal year as the demand for clinical and economic evidence remains high.

Furthermore, our development activities are intended to help reduce patient care costs and the length of hospital stays in the future.

We have not engaged in significant customer or government-sponsored research.

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.

Our R&D activities include improving existing products and therapies, expanding their indications and applications for use, and developing new therapies and procedures.

We also actively pursue innovation through selective external collaborations, investments, licensing arrangements, and acquisitions to access new technologies and capabilities.

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.

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Sales and Distribution

We sell our medical devices and therapies through a combination of direct sales representatives and independent distributors globally.

We sell our medical devices and therapies through a combination of direct sales representatives and third parties (e.g., independent distributors and agents) globally.

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, 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).

Our medical supply products are used primarily in hospitals, ASCs, physician offices, 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.

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.

To achieve this objective, our marketing and sales teams generally 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 support our customers and cross-sell complementary products.

In addition, we establish enterprise accounts encompassing the product portfolio, as appropriate to the purchasing dynamics in these strategic accounts.

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

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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.

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

In order to continue to compete effectively, we must be able to access advanced technologies and capabilities through a combination of internal development and strategic acquisitions or other business development initiatives.

Our ability to successfully incorporate these technologies into proprietary products, obtain regulatory approvals in a timely manner, maintain high-quality manufacturing processes, and effectively market these products is critical to sustaining our competitive position.

Government and private sector initiatives to limit the growth of healthcare costs, including price regulation, competitive pricing, bidding and tender mechanics, coverage and payment policies, comparative effectiveness of therapies, technology assessments and managed-care arrangements, are continuing in many countries where we do business, including the U.S.

These initiatives put increased emphasis on the delivery of more cost-effective medical devices and therapies.

Government programs, including Medicare and Medicaid, private healthcare insurance, managed-care plans, and volume-based procurement tenders in China, have attempted to control costs by limiting the amount of reimbursement they will pay for particular procedures or treatments, tying reimbursement to outcomes, shifting to population health management, and other mechanisms.

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reimbursement they will pay for particular procedures or treatments, tying reimbursement to outcomes, shifting to population health management, encouraging lower-cost sites of service, increasing use of utilization management programs (e.g., prior authorization), and other mechanisms.

Hospitals, which purchase our technology, are also seeking to reduce costs through a variety of mechanisms, including, for example, centralized purchasing, and in some cases, limiting the number of vendors that may participate in the purchasing program.

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For additional information related to our manufacturing facilities, refer to “Item 2.

Properties” in this Annual Report on Form 10-K.

Properties” of this Annual Report on Form 10-K.

Government Regulation

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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.

In addition, as a result of the release and availability of 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

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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.

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

FDA have, and could continue to have, an impact on product approval timelines and other types of agency oversight.

Regulations of the U.S.

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FDA and other regulatory bodies, both in and outside the U.S.

(including the Federal Trade Commission, the Office of the Inspector General of the Department of Health and Human Services, the U.S.

Department of Justice, and various state Attorneys General), monitor the promotion and advertising of our products.

(including the Federal Trade Commission, the Office of the Inspector General of the Department of Health and Human Services (HSS), the U.S.

Department of Justice,

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and various state Attorneys General), monitor the promotion and advertising of our products.

Any adverse regulatory action, depending on its magnitude, may limit our ability to effectively market and sell our products, limit our ability to obtain future pre-market approvals or result in a substantial modification to our business practices and operations.

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

We are subject to the risk that these laws and regulations could change in a way that would expose us to additional costs and burdens, as well as penalties if not complied with.

We are subject to the risk that these laws and regulations could change in a way that would expose us to additional costs and burdens, as well as penalties for non-compliance.

Some governments impose economic sanctions and other trade restrictions against certain countries, persons or entities.

We also sell and provide goods, technology and services to agents, representatives and distributors who may in turn sell or provide such items to customers and other end-users in their own countries or by means of their own cross-border transactions.

If we, or the third parties through which we do business, are not in compliance with applicable import, export control or economic sanctions laws and regulations, we may be subject to civil or criminal enforcement action, and varying degrees of liability.

If we, or the third parties through which we do business, are not in compliance with applicable import, export control or economic sanctions laws and regulations, including regulations related to the proper identification of the country of origin of our products, we may be subject to civil or criminal enforcement action, and varying degrees of liability.

Such actions may disrupt or delay sales of our products or services or result in restrictions on our distribution and sales of products or services that may materially impact our business.

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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, Federal, and International levels.

Our global operational footprint comes with the obligation for compliance and adherence to individual data security, confidentiality and breach notification laws at the U.S.

state, federal, and international levels.

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.

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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The delivery of our devices is subject to regulation by the U.S.

Department of Health and Human Services (HHS) and comparable state and non-U.S.

Department of HHS and comparable state and non-U.S.

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

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.

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.

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.

In addition, reported workforce reductions and agency reorganizations at HHS 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 U.S.

FDA-approved devices reimbursable by federal healthcare programs, we are

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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.

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We maintain a website at www.medtronic.com .

In addition to our primary website, we maintain a newsroom at https://news.medtronic.com and an investor relations website at https://investorrelations.medtronic.com .

We also use certain social media channels, including Facebook ( https://www.facebook.com/Medtronic ), X ( https://x.com/Medtronic ), and LinkedIn ( https://www.linkedin.com/company/medtronic/ ).

These websites and social media channels contain a significant amount of information about the Company, including financial and other information for investors.

We encourage investors to review the information we make available on these websites and social media channels, as information is frequently updated.

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).

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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.

Our website and the information contained on or connected to our website are not incorporated by reference into this Annual Report on Form 10-K.

The information contained on, or accessible through, our websites and social media channels is not incorporated by reference into this Annual Report on Form 10-K or in any other filings we make with the SEC.

The SEC maintains a website that contains reports, proxy, and information statements, and other information regarding issuers, including the Company, that file electronically with the SEC.

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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.

What changed 10-K

Item 1. Business