Growth is fueled by rising demand for advanced diagnostic systems, home-based monitoring solutions, and robotic-assisted surgical devices, alongside surging chronic disease prevalence and an aging population. Digital therapeutics and telehealth platforms are transforming patient care, enabling data-driven interventions for chronic and mental health conditions, while IoT-enabled devices and AI-powered diagnostics are redefining efficiency and clinical outcomes.
Chicago, Feb. 03, 2026 (GLOBE NEWSWIRE) — The U.S. medical devices market was valued at 184.5 billion in 2024 and is expected to reach US$ 311.50 billion by 2033, growing at a CAGR of 5.8% from 2025 to 2033.
The U.S. medical devices market is seeing an unprecedented growth in demand, boosted by technological leaps, aging demographics, and a surging focus on preventive care. Advanced home-based monitoring devices are increasingly adopted in cardiology and diabetes management, and at least 4,000 active American manufacturers are catering to these requirements in 2023. Meanwhile, robotic-assisted surgical units have risen to 2,300 installations this year, reflecting a drive for less invasive procedures. Notably, US-based medical device exporters have hit US$ 46 billion in global shipments, illustrating the country’s strong international footprint. Orthopedic implants have soared to annual procurement levels of US$ 15 billion across top-tier hospitals, while telehealth-compatible diagnostic tools have sold more than 5 million units nationwide in 2023.
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Leading device categories in the US medical devices market include next-generation diagnostic imaging systems, smart wearables for post-surgical follow-ups, and portable oxygen concentrators. More than 600 registered clinical trials are exploring regenerative medicine solutions, signifying how creation underpins market momentum. The surging adoption of IoT-enabled devices has led to grants totaling US$ 1.2 billion in 2023 for research into continuous patient monitoring technologies. This influx of funds has spurred strong competition among domestic players to improve device connectivity and data analytics. Sales are further boosted by the introduction of specialized reimbursement models by more than15 insurers, aiming to ease patient out-of-pocket costs.
Teleconsultations and App-Based Therapies Bridge Urban-Rural Gaps in Specialized Care
Digital therapeutics are rapidly reshaping how chronic diseases and mental health conditions are addressed, delivering data-driven interventions that complement or replace traditional treatments. In 2023, more than 200 digital therapeutics applications in the medical devices market in the US have received FDA clearance, reflecting an expanding acceptance by federal regulators. Investor funding in US digital therapeutics companies reached US$ 3.5 billion this year, showing strong confidence in these technology-driven solutions.
Teleconsultation requests through digital therapy platforms now exceed 10 million monthly sessions across the nation, bridging urban-rural gaps and bringing specialized care to remote counties. Moreover, at least 500 US-based hospitals have incorporated app-based therapy modules for diabetes and mood disorders, highlighting the institutional change toward tech-enabled patient support. Some advanced chronic disease management programs have documented a 12-day faster patient recovery window utilizing digital platforms, pointing to enhanced outcomes under real-world conditions.
Industry stakeholders in the US medical devices market see promise in these solutions as they align with emergent value-based healthcare models. US insurers have introduced about 40 specialized reimbursement programs specifically tailored for digital therapeutics, highlighting payors’ acknowledgment of the tangible advantages such technologies give. Beyond payment strategies, collaborations between health systems and tech firms are on the rise, harnessing real-time analytics to inform clinicians.
The scalability of digital therapeutics, allowing multiple users to benefit from a single platform, makes them specifically appealing in regions where specialist availability is limited. Associated with new protocols that seamlessly incorporate telehealth visits with wearable monitoring, these breakthroughs exemplify the transition toward proactive, data-centered care. As demand scales, digital therapeutics will likely become a core component in US patient management strategies, unfolding vast opportunities for innovators capable of delivering quantifiable advancements in clinical outcomes.
US Government Healthcare Spending Supports Medical Device Expansion
The US medical devices market is strongly led by diagnostic devices; this segment generated a revenue of US$ 83.59 billion in 2024. This dominance is primarily propelled by the high prevalence of chronic diseases requiring advanced diagnostic tools. For instance, the Centers for Disease Control and Prevention reported that in 2023, about 34.2 million Americans had diabetes, necessitating regular monitoring and diagnostics. Also, the American Cancer Society estimated that about 1.9 million new cancer cases would be diagnosed in 2023, increasing the demand for MRI and scintigraphy apparatus. The aging population is another significant factor; the U.S. Census Bureau projected that by 2030, the number of US residents aged 65 and older will reach 74 million, amplifying the need for diagnostic imaging due to age-related health issues.
Technological advancements and innovation also drive the medical devices market growth. Leading companies like General Electric (GE) Healthcare, Siemens Healthineers, and Philips Healthcare have been at the forefront of introducing cutting-edge diagnostic devices. GE Healthcare’s introduction of the SIGNA Premier MRI system expanded imaging abilities for complicated neurological and oncological cases. Siemens Healthineers reported installing more than 5,000 units of their Acuson Sequoia ultrasound system worldwide by 2023, demonstrating significant adoption.
The adoption of artificial intelligence in diagnostic devices has enhanced imaging analysis and efficiency. In 2020, Philips Healthcare established the Ingenia Ambition X 1.5T MR system, which uses AI for accelerated image acquisition. The US government’s substantial healthcare expenditure further supports this growth; according to the Centers for Medicare & Medicaid Services, national health spending reached US$ 3.8 trillion in 2024. Investment in research and development by key players fuels innovation; Medtronic, for instance, reported an R&D expenditure of US$ 2.3 billion in their 2023 annual report.
U.S. Medical Devices Market Major Players:
- Abbott
- Becton, Dickinson, and Company
- Boston Scientific Corporation
- Danaher
- F. Hoffmann-La Roche AG
- Johnson & Johnson
- Medtronic
- Siemens Healthineers AG
- Stryker
- Cardinal Health
- 3M Company
- Other Prominent Players
Key Market Segmentation:
By Product
- Diagnostic Devices
- Electrodiagnostic Devices
- Ultrasound Systems
- Magnetic Resonance Imaging (MRI)
- Electrocardiographs
- Scintigraphy Apparatus
- Other Electrodiagnostic Devices
- Radiation Devices
- CT Scanners
- Other Medical X-ray Apparatus
- Electrodiagnostic Devices
- Dental Products
- Dental Capital Equipment
- Dental X-Rays
- Other Medical Device Categories
- Ophthalmic Instruments
- Medical & Surgical Sterilizers
- Ultra-violet or Infra-Red Ray Apparatus
- Other Instruments & Appliances
- Medical Robots
- Drug Admixture Robotics
- Orthopaedic Robots
- Autonomous mobile robot
- Invasive Surgery Robots
- Others
- Aesthetics Equipment
- Fat Lipolysis Lasers
- Mechanical Exfoliation Equipment
- LED Light Therapy Equipment
- Conscious Sedation
- Others
- Laboratory equipment
- Coverslippers
- Cryostats
- Tissue Processor
- Digital Cell Morphology System
- Hematology Analyzers
- Automated coagulation System
- Hemoglobin Testing System
- Toxicology Analyzers
- Blood Culture System
- Biotyper System
- Automated Gram Stainer
- Others
- Interventional equipment
- Radiographic and Ultrasound equipment
- Angiographic system
- CT Scan Devices
- Microwave Ablation System
- Others
By End User
- Hospitals & Ambulatory Surgery Centers (ASCs)
- Clinics
- Others
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