United States Artificial Intelligence in Medical Devices Market 2025 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The Global Artificial Intelligence in Medical Devices Market reached US$ 21.50 billion in 2023 and is expected to reach US$ 228.98 billion by 2031, growing at a CAGR of 34.7% during the forecast period 2024-2031.

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Key Development:

United States: Recent Industry Developments

✅ In November 2025, Aidoc submitted to FDA its "multi-triage" AI-powered device built on its CARE foundation model aimed at flagging a wide array of acute, time-sensitive conditions across abdominal CT scans with high accuracy, marking a move toward broad-scope clinical AI tools.

✅ In September 2025, Aidoc received FDA "Breakthrough Device Designation" for its first-of-its-kind multi-triage AI solution for CT imaging, accelerating regulatory review given its potential to transform urgent diagnostic workflows.

✅ In June 2025, Hyperfine announced FDA clearance of a next-generation Swoop® MRI system powered by its proprietary AI software (Optive AI), a major technical upgrade intended to improve image quality, usability, and broaden adoption of portable MRI across hospital and clinical settings.

✅ On May 30, 2025, several AI-enabled medical devices received final FDA clearance, including Swoop® Portable MR Imaging System (V2) from Hyperfine, Inc., and BriefCase-Triage from Aidoc, reflecting continued regulatory activity in 2025 to expand AI-enabled imaging and triage tools in medical practice.

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Japan: Recent Industry Developments

✅ In October 2025, PMDA unveiled an agency-wide "Action Plan for Use of AI in Operations," committing to implement internal AI tools for regulatory operations, begin proof-of-concepts for specialized AI systems, and establish governance and training for AI use across its divisions.

✅ In June 2025, MedHub-AI secured PMDA approval for AutocathFFR® the world's first fully automated AI-driven FFR (Fractional Flow Reserve) software analyzing standard angiograms to assess coronary physiology, enabling non-invasive, wire-free coronary assessment in just tens of seconds.

✅ In 2025, Japanese regulatory and industry stakeholders signaled faster AI-medical device adoption under broader national policy shifts, supporting the use of AI-powered diagnostic tools such as image-based AI for endoscopy and radiology.

✅ In 2025, PMDA's internal modernization push through the Action Plan signals that Japan is preparing regulatory infrastructure to handle increasing AI-SaMD (Software as a Medical Device) submissions, which may accelerate evaluation and clearance of new AI-powered medical devices.

Key Players:

=> GE HealthCare., Medtronic, Siemens Healthineers AG, NVIDIA Corporation, Koninklijke Philips N.V., Canon Medical Systems, USA, Inc., Aidoc, IBM, Apple Inc., Google DeepMind, HYPERFINE, INC., and Clarius among others.

Emerging Players

The emerging players in the global artificial intelligence in medical devices market include Mediwhale Inc., xCures, Inc., and Formus Labs Ltd among others.

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Key Segments:

By Product Type

Hardware holds 25% share, driven by the adoption of AI-enabled imaging devices, high-performance GPUs, and specialized computing systems in hospitals and diagnostic centers. Software dominates with 50%, fueled by advanced AI algorithms for image analysis, diagnostics, predictive modeling, and workflow optimization. Services account for 25%, supported by implementation, integration, training, consulting, and ongoing maintenance services for AI-enabled medical imaging solutions.

By Technology

Machine Learning represents 30% share, widely adopted for predictive analytics, diagnostic assistance, and automated image interpretation. Deep Learning accounts for 25%, driven by superior accuracy in image recognition, segmentation, and disease detection across radiology and oncology. Natural Language Processing (NLP) holds 15%, supporting automated reporting, structured data extraction, and clinical documentation. Computer Vision makes up 20%, enabling precise image analysis for orthopedic imaging, cardiology scans, and hematology diagnostics. Others contribute 10%, including hybrid AI techniques and emerging algorithms for specialized imaging applications.

By Application

Radiology leads with 30% share, driven by AI-assisted imaging for early diagnosis, workflow efficiency, and integration with PACS systems. Cardiology accounts for 20%, supported by AI tools for echocardiography, ECG analysis, and predictive cardiac risk assessment. Hematology holds 10%, fueled by AI-assisted blood sample imaging and disease detection. Oncology represents 25%, driven by AI in tumor detection, treatment planning, and radiomics. Orthopedic Imaging contributes 10%, supported by AI-based fracture detection, joint analysis, and surgical planning. Others account for 5%, including neurology, gastroenterology, and ophthalmology imaging.

By End-User

Hospitals and Healthcare Providers dominate with 55% share, driven by high patient volumes, advanced diagnostic requirements, and adoption of AI for improved clinical outcomes. Pharmaceuticals and Biotechnology Companies hold 15%, using AI imaging for drug discovery, clinical trials, and biomarker analysis. Healthcare Payers account for 10%, leveraging AI for claim analysis, preventive care insights, and workflow optimization. Others represent 20%, including research institutes, academic centers, and telemedicine providers adopting AI-based imaging solutions.

By Region

North America - 40% Share
North America leads due to advanced healthcare infrastructure, high adoption of AI technologies, government support for healthcare innovation, and strong presence of AI imaging solution providers in the U.S. and Canada.

Europe - 25% Share
Europe holds 25%, supported by AI-friendly regulatory frameworks, increasing adoption in diagnostic centers, and investments in digital healthcare in Germany, U.K., France, Italy, and Scandinavia.

Asia Pacific - 20% Share
Asia Pacific accounts for 20%, driven by rising demand for diagnostic imaging, growing healthcare infrastructure, and AI adoption in hospitals and clinics across China, India, Japan, and Southeast Asia.

South America - 10% Share
South America contributes 10%, fueled by expansion of healthcare facilities, growing imaging centers, and adoption of AI-based diagnostics in Brazil, Argentina, and Chile.

Middle East & Africa - 5% Share
MEA represents 5%, supported by investments in healthcare modernization, telemedicine adoption, and AI-enabled imaging solutions in GCC countries, South Africa, and North Africa.

FAQ

What is the current size of the Artificial Intelligence in Medical Devices Market?

A: In 2023, the Artificial Intelligence in Medical Devices Market was valued at US$ 21.50 billion, reflecting its strong industry presence.

Q2: How large is the Artificial Intelligence in Medical Devices Market expected to be by 2031?

A: By 2031, industry forecasts suggest the Artificial Intelligence in Medical Devices Market will grow to around US$ 228.98 billion, demonstrating significant expansion.

Q3: What is the growth rate of the Artificial Intelligence in Medical Devices Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 34.7% during the forecast period from 2024 to 2031.

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