Artificial intelligence (AI) in medical devices refers to the integration of artificial intelligence technologies such as machine learning, deep learning, natural language processing, predictive analytics and context-aware computing into medical devices and healthcare systems to assist in diagnosis, monitoring, treatment planning, patient management and clinical decision-making. AI-enabled medical devices are designed to analyze large volumes of medical and patient-related data, identify patterns, automate workflows and support healthcare professionals in delivering accurate and efficient care.
The AI in medical devices market consists of sales of AI in medical devices by entities (organizations, sole traders and partnerships) through the development, production and sale of AI-integrated medical devices, AI-based healthcare software platforms and associated implementation and maintenance services. These devices and solutions are used by hospitals, healthcare providers, patients, pharmaceutical and biotechnology companies, healthcare payers and research institutions to improve operational efficiency, enhance patient outcomes, support early disease detection and optimize treatment procedures.
The global AI in medical devices market was valued $3,407.0 million in 2020 which grew till 2025 at a compound annual growth rate (CAGR) of more than 29.00%.
Rising Adoption Of Healthcare Cloud-Based AI Platforms
During the historic period, the AI in medical devices market was driven by the rising adoption of healthcare cloud-based AI platforms. As healthcare providers increasingly focused on improving clinical decision-making, enhancing operational efficiency and enabling data-driven patient care through integrated digital healthcare systems. For instance, in September 2025, according to HealthIT.gov, a US-based government health information technology platform, in the year 2024, 71% of hospitals reported using predictive AI integrated with electronic health records (EHRs), up from 66% in 2023, highlighting the growing adoption of cloud-based AI technologies and predictive healthcare analytics across healthcare systems. Therefore, the AI in medical devices market was driven by the rising adoption of healthcare cloud-based AI platforms during the historic period.
Digitalization, Cloud, Big Data And Cybersecurity
Companies operating in the AI in medical devices market are increasingly focusing on the adoption of cloud-based healthcare platforms, AI-native digital ecosystems and secure data integration frameworks to enhance patient engagement, real-time healthcare accessibility and interoperable medical intelligence. These innovations combine cloud computing infrastructure, agentic artificial intelligence, big data analytics and cybersecurity-driven data governance frameworks. For instance, in May 2026, Sanofi, a France-based biopharmaceutical company, launched AccelRare, an AI-powered pre-diagnosis platform designed to support the early identification of rare diseases in India. The platform utilizes AI algorithms, secure web-based infrastructure and data-driven diagnostic intelligence to analyze patient symptoms, medical history and laboratory findings, generating potential diagnoses for more than 300 rare diseases with high diagnostic reliability.
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.
AI In Medical Devices Global Market Opportunities And Strategies To 2035 from The Business Research Company 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.
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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 from The Business Research Company 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.
Markets Covered:
- 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."