The global AI in medical devices market reached a value of nearly $12.38 billion in 2025, having grown at a compound annual growth rate (CAGR) of 29.5% since 2020. The market is expected to grow from $12.38 billion in 2025 to $40.02 billion in 2030 at a rate of 26.4%. The market is then expected to grow at a CAGR of 24.3% from 2030 and reach $118.8 billion in 2035.
Growth in the historic period resulted from favorable government initiatives towards AI-enabled medical devices, rising adoption of healthcare cloud-based AI platforms, rising adoption of wearable medical devices and efforts towards early disease detection solutions. Factors that negatively affected growth in the historic period were concerns regarding data privacy and cybersecurity and high cost of AI medical devices.
Going forward, demand for improved diagnostic accuracy, increasing digital transformation in healthcare, growing demand for remote patient monitoring solutions and growing adoption of electronic health records (EHRs) will drive the growth. Factors that could hinder the growth of the AI in medical devices market in the future include stringent regulatory approval processes for medical devices, limited availability of skilled AI and healthcare professionals and impact of trade wars and tariffs.
Market trends for the AI in medical devices market include emphasis on the development of AI-enabled smart hemodialysis systems, connected renal care ecosystems and intelligent patient monitoring technologies, the development of AI-driven hemodynamic monitoring systems, predictive clinical decision support platforms and connected patient monitoring technologies, the development of AI-enabled point-of-care ultrasound (POCUS) devices, portable imaging platforms and workflow-optimized diagnostic systems and the development of AI-enabled advanced computed tomography (CT) imaging systems, intelligent workflow optimization platforms and low-dose diagnostic imaging technologies.
The AI in medical devices market is segmented by offerings into hardware, software and services. The software market was the largest segment of the AI in medical devices market segmented by offerings, accounting for 51.3% or $6.35 billion of the total in 2025. Going forward, the software segment is expected to be the fastest-growing segment in the AI in medical devices market segmented by offerings, at a CAGR of 30.9% during 2025-2030.
The AI in medical devices market is segmented by technology into context awareness, deep learning, machine learning, natural language processing, predictive analytics and other technologies. The machine learning market was the largest segment of the AI in medical devices market segmented by technology, accounting for 34.5% or $4.26 billion of the total in 2025. Going forward, the deep learning segment is expected to be the fastest-growing segment in the AI in medical devices market segmented by technology, at a CAGR of 32.7% during 2025-2030.
The AI in medical devices market is segmented by deployment into cloud and on-premises. The cloud market was the largest segment of the AI in medical devices market segmented by deployment, accounting for 66.4% or $8.22 billion of the total in 2025. Going forward, the cloud segment is expected to be the fastest-growing segment in the AI in medical devices market segmented by deployment, at a CAGR of 27.2% during 2025-2030.
The AI in medical devices market is segmented by application into patient care, treatment, diagnosis and monitoring and other applications. The diagnosis and monitoring market was the largest segment of the AI in medical devices market segmented by application, accounting for 41.8% or $5.17 billion of the total in 2025. Going forward, the diagnosis and monitoring segment is expected to be the fastest-growing segment in the AI in medical devices market segmented by application, at a CAGR of 30.5% during 2025-2030.
The AI in medical devices market is segmented by end-user into hospitals and healthcare providers, homecare settings, pharmaceutical and biotechnology companies and other end users. The hospitals and healthcare providers market was the largest segment of the AI in medical devices market segmented by end-user, accounting for 67.9% or $8.4 billion of the total in 2025. Going forward, the hospitals and healthcare providers segment is expected to be the fastest-growing segment in the AI in medical devices market segmented by end-user, at a CAGR of 27.4% during 2025-2030.
North America was the largest region in the AI in medical devices market, accounting for 40.4% or $5.0 billion of the total in 2025. It was followed by Asia-Pacific, Western Europe and then the other regions. Going forward, the fastest-growing regions in the AI in medical devices market will be Asia-Pacific and Middle East where growth will be at CAGRs of 30.3% and 26.8% respectively. These will be followed by Africa and South America where the markets are expected to grow at CAGRs of 26.4% and 25.8% respectively.
The global AI in medical devices market is fragmented, with a large number of small players operating in the market. The top 10 competitors in the market made up 6.8% of the total market in 2025. Medtronic Plc was the largest competitor with a 1.55% share of the market, followed by GE HealthCare Technologies Inc. with 1.00%, Siemens Healthineers AG with 0.86%, Koninklijke Philips N.V. with 0.82%, NVIDIA Corporation with 0.78%, Intuitive Surgical Inc. with 0.50%, Stryker Corporation with 0.45%, Canon Inc. with 0.37%, Zimmer Biomet Holdings Inc. with 0.27% and Intel Corporation with 0.25%.
The top opportunities in the AI in medical devices market segmented by offerings will arise in the software segment, which will gain $18.01 billion of global annual sales by 2030. The top opportunities in the AI in medical devices market segmented by technology will arise in the machine learning segment, which will gain $10.27 billion of global annual sales by 2030. The top opportunities in the AI in medical devices market segmented by deployment will arise in the cloud segment, which will gain $19.13 billion of global annual sales by 2030. The top opportunities in the AI in medical devices market segmented by application will arise in the diagnosis and monitoring segment, which will gain $14.4 billion of global annual sales by 2030. The top opportunities in the AI in medical devices market segmented by end-user will arise in the hospitals and healthcare providers segment, which will gain $19.85 billion of global annual sales by 2030. The AI in medical devices market size will gain the most in the USA at $8.62 billion.
Player-adopted strategies in the AI in medical devices market include focus on enhancing its business operations through strategic partnerships and expanding its business capabilities through new launches.
Market-trend-based strategies for the AI in medical devices market include focus on the development of AI-enabled smart hemodialysis systems, connected renal care ecosystems and intelligent patient monitoring technologies, the development of AI-driven hemodynamic monitoring systems, predictive clinical decision support platforms and connected patient monitoring technologies, the development of AI-enabled point-of-care ultrasound (POCUS) devices, portable imaging platforms and workflow-optimized diagnostic systems and the development of AI-enabled advanced computed tomography (CT) imaging systems, intelligent workflow optimization platforms and low-dose diagnostic imaging technologies.
To take advantage of the opportunities, the analyst recommends the AI in medical devices companies to focus on AI enabled dialysis ecosystems for connected renal care expansion, focus on AI driven hemodynamic monitoring for predictive clinical decision support, focus on AI enabled point of care ultrasound for rapid diagnostic expansion, focus on AI enabled CT imaging systems for high precision diagnostic advancement, focus on ai medical device software platforms for scalable healthcare intelligence, focus on deep learning driven AI platforms in medical devices, focus on AI-enabled diagnosis and monitoring systems for scalable clinical impact, focus on value-based and tiered pricing models for AI medical devices, focus on clinical evidence led promotion and hospital decision maker targeting, focus on digital clinical ecosystems and multi channel medical education campaigns, focus on AI integration across hospitals and healthcare provider ecosystems.
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Table of Contents
Executive Summary
AI In Medical Devices Global Market Opportunities And Strategies To 2035 provides the strategists; marketers and senior management with the critical information they need to assess the global AI in medical devices market as it emerges from the COVID-19 shut down.Reasons to Purchase
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Description
Where is the largest and fastest-growing market for AI in medical devices? How does the market relate to the overall economy; demography and other similar markets? What forces will shape the market going forward? The AI in medical devices market global report answers all these questions and many more.The report covers market characteristics; size and growth; segmentation; regional and country breakdowns; competitive landscape; market shares; trends and strategies for this market. It traces the market’s history and forecasts market growth by geography. It places the market within the context of the wider AI in medical devices market; and compares it with other markets.
The report covers the following chapters:
- Introduction And Market Characteristics - Brief introduction to the segmentations covered in the market, definitions and explanations about the segments, key products, supply chain and market attractiveness scoring and analysis.
- Key Trends - Highlights the major trends shaping the global market. This section also highlights likely future developments in the market.
- Growth Analysis And Strategic Analysis Framework - Analysis on PESTEL, end use industries, market growth rate, global historic (2020-2025) and forecast (2025-2030, 2035F) market values and drivers and restraints that support and control the growth of the market in the historic and forecast periods, forecast growth contributors and total addressable market (TAM).
- Regional And Country Analysis - Historic (2020-2025) and forecast (2025-2030, 2035F) market values and growth and market share comparison by region and country.
- Market Segmentation - Contains the market values (2020-2025) (2025-2030, 2035F) and analysis for each segment by offerings, by technology, by deployment, by application and by end-user in the market. Historic (2020-2025) and forecast (2025-2030) and (2030-2035) market values and growth and market share comparison by region market.
- Regional Market Size And Growth - Regional market size (2025), historic (2020-2025) and forecast (2025-2030, 2035F) market values and growth and market share comparison of countries within the region. This report includes information on all the regions Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa and major countries within each region.
- Competitive Landscape - Details on the competitive landscape of the market, estimated market shares and company profiles of the leading players.
- Other Major And Innovative Companies - Details on the company profiles of other major and innovative companies in the market.
- Competitive Benchmarking - Briefs on the financials comparison between major players in the market.
- Competitive Dashboard - Briefs on competitive dashboard of major players.
- Key Mergers And Acquisitions - Information on recent mergers and acquisitions in the market covered in the report. This section gives key financial details of mergers and acquisitions, which have shaped the market in recent years.
- Recent Developments - Information on recent developments in the market covered in the report.
- Future Outlook And Potential Analysis Contains information on growth opportunities across countries, segments and strategies to be followed in those markets. It gives an understanding of where there is significant business to be gained by competitors in the next five years.
- Market Opportunities And Strategies Describes market opportunities and strategies based on findings of the research, with information on growth opportunities across countries, segments and strategies to be followed in those markets.
- Conclusions And Recommendations This section includes recommendations for AI in medical devices providers in terms of product/service offerings geographic expansion, marketing strategies and target groups.
- Appendix - This section includes details on the NAICS codes covered, abbreviations and currencies codes used in this report.
1) By Offerings: Hardware; Software; Services
2) By Technology: Context Awareness; Deep learning; Machine learning; Natural Language Processing; Predictive Analytics; Other Technologies
3) By Deployment: Cloud; On-Premises
4) By Application: Patient Care; Treatment; Diagnosis And Monitoring; Other Applications
5) By End-User: Hospitals And Healthcare Providers; Homecare Settings; Pharmaceutical And Biotechnology Companies; Other End Users
Companies Mentioned: Medtronic Plc; GE HealthCare Technologies Inc.; Siemens Healthineers AG; Koninklijke Philips N.V.; NVIDIA Corporation
Countries: China; Australia; India; Indonesia; Japan; Taiwan; South Korea; USA; Canada; Brazil; France; Germany; UK; Italy; Spain; Russia
Regions: Asia-Pacific; South East Asia; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
Time Series: Five years historic and ten years forecast.
Data: Ratios of market size and growth to related markets; GDP proportions; expenditure per capita; AI in medical devices indicators comparison.
Data segmentations: country and regional historic and forecast data; market share of competitors; market segments.
Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
Companies Mentioned
- Medtronic Plc
- GE HealthCare Technologies Inc.
- Siemens Healthineers AG
- Koninklijke Philips N.V.
- NVIDIA Corporation
- Intuitive Surgical Inc.
- Stryker Corporation
- Canon Inc.
- Zimmer Biomet Holdings Inc.
- Intel Corporation
- Trivitron Healthcare
- S10 Health Solutions
- Predible Health
- Artelus
- Cochlear Limited
- Canon Medical Systems Corporation
- Mindray Medical International Limited
- United Imaging Healthcare Co., Ltd.
- Wandong Medical Co., Ltd.
- Yizumi Group
- Shinva Medical Instrument Co., Ltd.
- Wellesta Holdings
- CloudMedx
- Qure.ai
- Trivitron Healthcare
- Canon Medical Systems Corporation
- Philips
- GE HealthCare
- Roche
- Sectra
- Canon Medical Systems
- Aidoc
- Butterfly Network
- IBM
- Canon Medical Systems
- General Electric Company
- Pathcore
- Synaptive Medical
- Cloud DX
- BenchSci
- Thornhill Medical
- Google Health
- Philips Healthcare
- International Business Machines Corporation
- PathAI Inc.
- Aidoc Medical Ltd.
- Arterys Inc.
- Intel Corporation
- Brainomix Ltd.

