This report describes and explains the artificial intelligence or machine learning (AI/ML) medical devices market and covers 2020-2025, termed the historic period, and 2025-2030, 2035F termed the forecast period. The report evaluates the market across each region and for the major economies within each region.
The global artificial intelligence or machine learning (AI/ML) medical device market reached a value of nearly $7.33 billion in 2025, having grown at a compound annual growth rate (CAGR) of 24.7% since 2020. The market is expected to grow from $7.33 billion in 2025 to $21.75 billion in 2030 at a rate of 24.3%. The market is then expected to grow at a CAGR of 22.4% from 2030 and reach $59.89 billion in 2035.
Growth in the historic period resulted from shift to home-based care, rise in explosion of healthcare data, rising adoption of healthcare cloud-based ai platforms and increasing clinical trials and research activities. Factors that negatively affected growth in the historic period were high cost of AI/ML medical devices and stringent regulatory requirements.
Going forward, favorable government initiatives towards AI-enabled medical devices, demand for improved diagnostic accuracy, rising prevalence of chronic diseases and increasing digital transformation in healthcare will drive the growth. Factors that could hinder the growth of the artificial intelligence or machine learning (AI/ML) medical device market in the future include data privacy and security concerns, integration with legacy healthcare IT systems and impact of trade and tariffs.
Market trends for the artificial intelligence or machine learning (AI/ML) medical device market include emphasis on artificial intelligence (AI) and machine learning (ML) to enhance real-time diagnostic accuracy, automated clinical decision support, and data-driven patient care optimization, digitalization, cloud computing, big data analytics, and cybersecurity to enhance real-time clinical decision support, remote patient monitoring, and AI-driven diagnostic workflows and Industry 4.0 and intelligent manufacturing to enhance real-time device performance monitoring, automated quality assurance, and connected production and clinical data workflows while reducing reliance on manual calibration, isolated testing systems, and fragmented device data that limit scalability and regulatory compliance across medical device ecosystems.
The artificial intelligence or machine learning (AI/ML) medical device market is segmented by product into system or hardware and software-as-a medical devices. The software-as-a medical devices market was the largest segment of the artificial intelligence or machine learning (AI/ML) medical device market segmented by product, accounting for 61.6% or $4.51 billion of the total in 2025. Going forward, the software-as-a medical devices segment is expected to be the fastest-growing segment in the artificial intelligence or machine learning (AI/ML) medical device market segmented by product, at a CAGR of 26.9% during 2025-2030.
The artificial intelligence or machine learning (AI/ML) medical device market is segmented by clinical area into radiology, cardiology, hematology and other clinical areas. The radiology was the largest segment of the artificial intelligence or machine learning (AI/ML) medical device market segmented by clinical area, accounting for 81.2% or $5.95 billion of the total in 2025. Going forward, the radiology segment is expected to be the fastest-growing segment in the artificial intelligence or machine learning (AI/ML) medical device market segmented by clinical area, at a CAGR of 25.5% during 2025-2030.
The artificial intelligence or machine learning (AI/ML) medical device market is segmented by end-user into food, beverages, pharmaceuticals, personal care, chemicals and other end users. The hospitals and healthcare providers market was the largest segment of the artificial intelligence or machine learning (AI/ML) medical device market segmented by end-user, accounting for 46.6% or $3.41 billion of the total in 2025. Going forward, the pharmaceuticals and biotechnology companies segment is expected to be the fastest-growing segment in the artificial intelligence or machine learning (AI/ML) medical device market segmented by end-user, at a CAGR of 32.5% during 2025-2030.
The global artificial intelligence or machine learning (AI/ML) medical device market is fairly fragmented, with a large number of small players operating in the market. The top 10 competitors in the market made up 10.17% of the total market in 2024. Siemens Healthneers AG was the largest competitor with a 1.75% share of the market, followed by GE Healthcare Technologies Inc. with 1.41%, Koninklijke Philips N.V. with 1.37%, Tempus AI Inc. with 1.23%, Canon Inc. (Canon Medical Systems) with 1.20%, Fujifilm Holdings with 0.86%, Meditronic plc with 0.82%, Shanghai United Imaging Healthcare Co. Ltd. (United Imaging Healthcare) with 0.60%, Aiolos Engineering Corporation with 0.53% and Stryker Corp. with 0.40%.
The top opportunities in the artificial intelligence or machine learning (AI/ML) medical device market segmented by product will arise in the software-as-a medical devices segment, which will gain $10.33 billion of global annual sales by 2030. The top opportunities in the artificial intelligence or machine learning (AI/ML) medical device market segmented by clinical area will arise in the radiology segment, which will gain $12.54 billion of global annual sales by 2030. The top opportunities in the artificial intelligence or machine learning (AI/ML) medical device market segmented by end-user will arise in the pharmaceuticals and biotechnology companies segment, which will gain $6.28 billion of global annual sales by 2030. The artificial intelligence or machine learning (AI/ML) medical device market size will gain the most in the USA at $5.74 billion.
Player-adopted strategies in the artificial intelligence or machine learning (AI/ML) medical device market include focus on strengthening its business operations through new launches and strengthening its business operations through strategic partnerships.
Market-trend-based strategies for the artificial intelligence or machine learning (AI/ML) medical device market include focus on the development and introduction of clinician-in-the-loop AI systems that leverage advanced machine learning algorithms, real-time data integration, and interactive decision-support features to enhance diagnostic accuracy, treatment planning, and patient outcomes, the development and introduction of multi-modal AI systems that leverage advanced machine learning algorithms, integration of diverse imaging and clinical data, and automated decision-support features to enhance diagnostic accuracy, clinical workflow efficiency, and patient outcomes, the development and introduction of AI-driven quality assurance systems that leverage advanced algorithm validation frameworks, automated data integrity checks, and integrated monitoring features to enhance model reliability, regulatory compliance, and clinical performance and the development and introduction of edge AI technologies that leverage on-device machine learning models, optimized data processing pipelines, and integrated computational acceleration features to enable fast, real-time clinical decision support, diagnostic accuracy, and workflow efficiency.
To take advantage of the opportunities, the analyst recommends the artificial intelligence or machine learning (AI/ML) medical device companies to focus on clinician-in-the-loop ai systems to strengthen trust and clinical adoption, focus on multi-modal ai systems to enhance diagnostic accuracy and workflow efficiency, focus on ai-driven quality assurance systems to improve reliability and compliance, focus on edge ai technologies to enable real-time clinical decision support, focus on software-as-a-medical devices for high-impact scalable growth, focus on radiology for scalable growth and market leadership, expand in emerging markets, continue to focus on developed markets, focus on expanding multi-channel distribution networks for ai/ml medical devices, focus on value-based and tiered pricing for ai/ml medical devices, focus on evidence-led promotion strategy for ai/ml medical devices, focus on integration-focused promotion and market activation, focus on pharmaceuticals and biotechnology companies for high-growth expansion.
This product will be delivered within 3-5 business days.
The global artificial intelligence or machine learning (AI/ML) medical device market reached a value of nearly $7.33 billion in 2025, having grown at a compound annual growth rate (CAGR) of 24.7% since 2020. The market is expected to grow from $7.33 billion in 2025 to $21.75 billion in 2030 at a rate of 24.3%. The market is then expected to grow at a CAGR of 22.4% from 2030 and reach $59.89 billion in 2035.
Growth in the historic period resulted from shift to home-based care, rise in explosion of healthcare data, rising adoption of healthcare cloud-based ai platforms and increasing clinical trials and research activities. Factors that negatively affected growth in the historic period were high cost of AI/ML medical devices and stringent regulatory requirements.
Going forward, favorable government initiatives towards AI-enabled medical devices, demand for improved diagnostic accuracy, rising prevalence of chronic diseases and increasing digital transformation in healthcare will drive the growth. Factors that could hinder the growth of the artificial intelligence or machine learning (AI/ML) medical device market in the future include data privacy and security concerns, integration with legacy healthcare IT systems and impact of trade and tariffs.
Market trends for the artificial intelligence or machine learning (AI/ML) medical device market include emphasis on artificial intelligence (AI) and machine learning (ML) to enhance real-time diagnostic accuracy, automated clinical decision support, and data-driven patient care optimization, digitalization, cloud computing, big data analytics, and cybersecurity to enhance real-time clinical decision support, remote patient monitoring, and AI-driven diagnostic workflows and Industry 4.0 and intelligent manufacturing to enhance real-time device performance monitoring, automated quality assurance, and connected production and clinical data workflows while reducing reliance on manual calibration, isolated testing systems, and fragmented device data that limit scalability and regulatory compliance across medical device ecosystems.
The artificial intelligence or machine learning (AI/ML) medical device market is segmented by product into system or hardware and software-as-a medical devices. The software-as-a medical devices market was the largest segment of the artificial intelligence or machine learning (AI/ML) medical device market segmented by product, accounting for 61.6% or $4.51 billion of the total in 2025. Going forward, the software-as-a medical devices segment is expected to be the fastest-growing segment in the artificial intelligence or machine learning (AI/ML) medical device market segmented by product, at a CAGR of 26.9% during 2025-2030.
The artificial intelligence or machine learning (AI/ML) medical device market is segmented by clinical area into radiology, cardiology, hematology and other clinical areas. The radiology was the largest segment of the artificial intelligence or machine learning (AI/ML) medical device market segmented by clinical area, accounting for 81.2% or $5.95 billion of the total in 2025. Going forward, the radiology segment is expected to be the fastest-growing segment in the artificial intelligence or machine learning (AI/ML) medical device market segmented by clinical area, at a CAGR of 25.5% during 2025-2030.
The artificial intelligence or machine learning (AI/ML) medical device market is segmented by end-user into food, beverages, pharmaceuticals, personal care, chemicals and other end users. The hospitals and healthcare providers market was the largest segment of the artificial intelligence or machine learning (AI/ML) medical device market segmented by end-user, accounting for 46.6% or $3.41 billion of the total in 2025. Going forward, the pharmaceuticals and biotechnology companies segment is expected to be the fastest-growing segment in the artificial intelligence or machine learning (AI/ML) medical device market segmented by end-user, at a CAGR of 32.5% during 2025-2030.
The global artificial intelligence or machine learning (AI/ML) medical device market is fairly fragmented, with a large number of small players operating in the market. The top 10 competitors in the market made up 10.17% of the total market in 2024. Siemens Healthneers AG was the largest competitor with a 1.75% share of the market, followed by GE Healthcare Technologies Inc. with 1.41%, Koninklijke Philips N.V. with 1.37%, Tempus AI Inc. with 1.23%, Canon Inc. (Canon Medical Systems) with 1.20%, Fujifilm Holdings with 0.86%, Meditronic plc with 0.82%, Shanghai United Imaging Healthcare Co. Ltd. (United Imaging Healthcare) with 0.60%, Aiolos Engineering Corporation with 0.53% and Stryker Corp. with 0.40%.
The top opportunities in the artificial intelligence or machine learning (AI/ML) medical device market segmented by product will arise in the software-as-a medical devices segment, which will gain $10.33 billion of global annual sales by 2030. The top opportunities in the artificial intelligence or machine learning (AI/ML) medical device market segmented by clinical area will arise in the radiology segment, which will gain $12.54 billion of global annual sales by 2030. The top opportunities in the artificial intelligence or machine learning (AI/ML) medical device market segmented by end-user will arise in the pharmaceuticals and biotechnology companies segment, which will gain $6.28 billion of global annual sales by 2030. The artificial intelligence or machine learning (AI/ML) medical device market size will gain the most in the USA at $5.74 billion.
Player-adopted strategies in the artificial intelligence or machine learning (AI/ML) medical device market include focus on strengthening its business operations through new launches and strengthening its business operations through strategic partnerships.
Market-trend-based strategies for the artificial intelligence or machine learning (AI/ML) medical device market include focus on the development and introduction of clinician-in-the-loop AI systems that leverage advanced machine learning algorithms, real-time data integration, and interactive decision-support features to enhance diagnostic accuracy, treatment planning, and patient outcomes, the development and introduction of multi-modal AI systems that leverage advanced machine learning algorithms, integration of diverse imaging and clinical data, and automated decision-support features to enhance diagnostic accuracy, clinical workflow efficiency, and patient outcomes, the development and introduction of AI-driven quality assurance systems that leverage advanced algorithm validation frameworks, automated data integrity checks, and integrated monitoring features to enhance model reliability, regulatory compliance, and clinical performance and the development and introduction of edge AI technologies that leverage on-device machine learning models, optimized data processing pipelines, and integrated computational acceleration features to enable fast, real-time clinical decision support, diagnostic accuracy, and workflow efficiency.
To take advantage of the opportunities, the analyst recommends the artificial intelligence or machine learning (AI/ML) medical device companies to focus on clinician-in-the-loop ai systems to strengthen trust and clinical adoption, focus on multi-modal ai systems to enhance diagnostic accuracy and workflow efficiency, focus on ai-driven quality assurance systems to improve reliability and compliance, focus on edge ai technologies to enable real-time clinical decision support, focus on software-as-a-medical devices for high-impact scalable growth, focus on radiology for scalable growth and market leadership, expand in emerging markets, continue to focus on developed markets, focus on expanding multi-channel distribution networks for ai/ml medical devices, focus on value-based and tiered pricing for ai/ml medical devices, focus on evidence-led promotion strategy for ai/ml medical devices, focus on integration-focused promotion and market activation, focus on pharmaceuticals and biotechnology companies for high-growth expansion.
This product will be delivered within 3-5 business days.
Table of Contents
1 Executive Summary
6 Market Characteristics
8 Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Attractiveness Scoring and Analysis
9 Major Market Trends
10 Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Growth Analysis and Strategic Analysis Framework
11 Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Size and Growth Analysis
12 Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Total Addressable Market (TAM) Analysis
13 Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Segmentation
14 Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market, Regional and Country Analysis
15 Asia-Pacific Market
16 South East Asia Market
17 North America Market
18 Western Europe Market
19 South America Market
20 Eastern Europe Market
21 Middle East Market
22 Africa Market
23 Competitive Landscape and Company Profiles
24 Other Major and Innovative Companies
27 Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market - Company Scoring Matrix
29 Key Mergers and Acquisitions
30 Recent Developments in Artificial Intelligence or Machine Learning (AI/ML) Medical Device
31 Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market, Key Regulatory Trends
32 Opportunities and Strategies
33 Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market, Conclusions and Recommendations
34 Appendix
Executive Summary
Artificial Intelligence Or Machine Learning (AI/ML) 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 artificial intelligence or machine learning (AI/ML) medical devices market as it emerges from the COVID-19 shut down.Reasons to Purchase
- Gain a truly global perspective with the most comprehensive report available on this market covering 16 geographies.
- Understand how the market is being affected by the coronavirus and how it is likely to emerge and grow as the impact of the virus abates.
- Create regional and country strategies on the basis of local data and analysis.
- Identify growth segments for investment.
- Outperform competitors using forecast data and the drivers and trends shaping the market.
- Understand customers based on the latest market research findings.
- Benchmark performance against key competitors.
- Utilize the relationships between key data sets for superior strategizing.
- Suitable for supporting your internal and external presentations with reliable high-quality data and analysis.
Description
Where is the largest and fastest-growing market for artificial intelligence or machine learning (AI/ML) medical device ? How does the market relate to the overall economy; demography and other similar markets? What forces will shape the market going forward? The artificial intelligence or machine learning (AI/ML) medical device 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 artificial intelligence or machine learning (AI/ML) medical device; 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 technologies and 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).
- Global Market Size and Growth 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.
- 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 product, by clinical area 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 startups, 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.
- 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 artificial intelligence or machine learning (AI/ML) medical device 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 Product: System Or Hardware; Software-As-A Medical Devices
2) By Clinical Area: Radiology; Cardiology; Hematology; Other Clinical Areas
3) By End User: Food; Beverages; Pharmaceuticals; Personal Care; Chemicals; Other End Users
Companies Mentioned: Siemens Healthineers AG; GE Healthcare Technologies Inc.; Koninklijke Philips N.V.; Tempus AI Inc.; Canon Inc.
Countries: China; Australia; India; Indonesia; Japan; South Korea; Taiwan; 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; artificial intelligence or machine learning (AI/ML) 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
- Siemens Healthineers AG
- GE Healthcare Technologies Inc.
- Koninklijke Philips N.V.
- Tempus AI Inc.
- Canon Inc.
- Fujifilm Holdings
- Medtronic plc
- Shanghai United Imaging Healthcare Co. Ltd. (United Imaging Healthcare)
- Aidoc Medical Ltd.
- Stryker Corp
- Alcidion Group
- Elekta
- Hyperfine Inc.
- L&T Technology Services (LTTS)
- Aorui Biotech
- United Imaging Healthcare
- SenseTime
- iFLYTEK
- Infervision
- Beijing Deepwise Science And Technology Co. Ltd.
- Yitu Technology
- AI Medical Service Inc.
- LPIXEL Inc.
- Hitachi Healthcare
- NEC Corporation
- Medmain Inc.
- Deepnoid
- VUNO Inc.
- Lunit Inc.
- Mediwhale Inc.
- Coreline Soft Co. Ltd.
- AItrics Co. Ltd.
- JLK Inc.
- General Electric Company
- CellaVision AB
- Clarius Mobile Health
- Subtle Medical
- Owkin
- Odin Vision
- Aiforia
- Rudolf Riester GmbH
- UltraSight
- Boston Scientific
- icometrix
- Roche Holding AG
- Klineo
- Carl Zeiss Meditec AG
- Tandem Health
- Teoresi Group
- Klaris
- Aireen
- Datlowe
- Upheal
- Infermedica
- BioCam
- Cardiomatics
- AILIS
- Rayscape
- Advalange
- Neurobotics
- Botkin.AI
- Carebot
- Kardi Ai
- Synaptiq
- Median Technologies
- CorVent Medical
- iRhythm Technologies
- Remmie Health
- IBM Watson Health
- Google Health
- Microsoft Healthcare
- Zebra Medical Vision
- Viz.ai
- HeartFlow
- AliveCor
- Qure.ai
- FluidAI Medical Inc.
- HealWELL AI Inc.
- Treatment.com AI Inc.
- AI/ML Innovations Inc.
- Eretz.bio
- Bracco Imaging S.p.A.
- MedLatam
- Doutor-AI
- IAssist Tecnologi
- Medvise
- Aimedic
- Ibex Medical Analytics
- Healthy.io
- EarlySense
- CardiacSense Ltd
- Philips UAE
- AISAP
- TytoCare
- DilenyTech
- RxAll
- MDaaS Global
- Healthtracka
- Innohealth Technologies
- Vula Medical
- Ilara Health
- Ubenwa
- AjirMed
- AI Diagnostics
