The artificial intelligence or machine learning (ai/ml) medical device market size has grown exponentially in recent years. It will grow from $8.11 billion in 2025 to $10.24 billion in 2026 at a compound annual growth rate (CAGR) of 26.2%. The growth in the historic period can be attributed to growth of medical imaging adoption, shortage of healthcare professionals, increase in chronic disease prevalence, digitalization of healthcare data, advancements in medical device technology.
The artificial intelligence or machine learning (ai/ml) medical device market size is expected to see exponential growth in the next few years. It will grow to $26.46 billion in 2030 at a compound annual growth rate (CAGR) of 26.8%. The growth in the forecast period can be attributed to rising adoption of precision medicine, expansion of telehealth services, regulatory approvals for AI medical devices, demand for early disease detection, growth of value-based healthcare models. Major trends in the forecast period include ai-powered diagnostic imaging, clinical decision support systems, remote patient monitoring devices, predictive healthcare analytics, robotic-assisted medical procedures.
Growing investments in healthcare AI are anticipated to drive the expansion of the artificial intelligence and machine learning medical device market in the coming years. Healthcare AI refers to the use of artificial intelligence technologies within the healthcare sector to enhance diagnosis, treatment, service delivery, and overall patient care. Increased funding in healthcare AI is largely fueled by the ability of AI and ML to transform healthcare operations, improve clinical outcomes, and boost efficiency. For example, in March 2023, data from the Department of Health and Social Care, a UK-based government body, indicated that more than 300,000 patients benefited from $147.2 million (£123 million) invested across 86 AI technologies through three funding rounds. In addition, Mendelian, a UK-based digital health startup, received $1.7 million (£1.4 million) to support the development of an AI system aimed at identifying patients with undiagnosed rare conditions. Furthermore, Medtronic, a US-based medical device manufacturer, was granted $3.18 million (£2.5 million) to advance the development of its AI-powered medical device, GI Genius. As a result, rising investments in healthcare AI continue to accelerate the growth of the artificial intelligence and machine learning medical device market.
Leading companies operating in the artificial intelligence and machine learning medical device market are concentrating on the development of advanced technologies such as AI-driven performance insights to improve surgical accuracy, streamline clinical workflows, and enhance patient outcomes through data-supported decision-making. AI-driven Performance Insights refers to an advanced analytical system that utilizes artificial intelligence algorithms to evaluate surgical videos and produce practical insights aimed at improving surgical efficiency, performance, and training. For instance, in April 2024, Medtronic plc, an Ireland-based medical device company, introduced 14 new AI-driven Performance Insights algorithms along with Touch Surgery Live Stream technology to support laparoscopic and robotic-assisted surgeries. These innovations enable AI-powered post-operative analysis with in-depth evaluation of surgical techniques and provide real-time remote viewing to strengthen surgical education and collaboration, establishing a new standard in AI-enabled surgical performance.
In April 2024, GE HealthCare, a US-based medical technology and digital solutions provider, acquired MIM Software for an undisclosed sum. With this acquisition, GE HealthCare seeks to enhance its AI-driven imaging and workflow solutions across oncology, urology, neurology, and cardiology by incorporating MIM Software’s advanced image analysis and multi-modality processing technologies. MIM Software is a US-based medical imaging software company that develops artificial intelligence and machine learning-enabled solutions for image analysis, processing, and treatment planning.
Major companies operating in the artificial intelligence or machine learning (ai/ml) medical device market are General Electric; Medtronic PLC; Canon Inc.; Nvidia Corporation; Siemens Healthineers AG; Koninklijke Philips N.V.; Stryker Corporation; RadNet Inc.; ShanghAI United Imaging Healthcare Co. Ltd.; Tempus; DataRobot Inc.; DeepMind Technologies Limited; Paige AI Inc.; Aidoc Medical Ltd.; Butterfly Network Inc.; Aidoc Medical; CellaVision AB; Clarius Mobile Health Corp.; Subtle Medical Inc.; Owkin Inc.; Cleerly Inc.; Behold.ai; Viz.AI Inc.; Arterys Inc.; Caption Health; Enlitic Inc.; Hyperfine Inc.; Nanox AI Ltd.
North America was the largest region in the artificial intelligence machine learning (AI/ML) medical device market in 2025. The regions covered in the artificial intelligence or machine learning (ai/ml) medical device market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the artificial intelligence or machine learning (ai/ml) medical device market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Tariffs have moderately affected the AI or machine learning medical device market by increasing costs of imported sensors, imaging components, and advanced processing units. Diagnostic imaging and robotic-assisted devices are most impacted, particularly in asia-pacific manufacturing hubs. Higher device costs can limit adoption in cost-sensitive healthcare systems. However, tariffs are encouraging localized manufacturing and software-centric innovation. This shift is supporting supply chain resilience and long-term market sustainability.
The artificial intelligence or machine learning (ai/ml) medical device market research report is one of a series of new reports that provides artificial intelligence or machine learning (ai/ml) medical device market statistics, including artificial intelligence or machine learning (ai/ml) medical device industry global market size, regional shares, competitors with a artificial intelligence or machine learning (ai/ml) medical device market share, detailed artificial intelligence or machine learning (ai/ml) medical device market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence or machine learning (ai/ml) medical device industry. This artificial intelligence or machine learning (ai/ml) medical device market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
An AI/ML medical device, short for artificial intelligence or machine learning medical device, refers to a medical device that integrates artificial intelligence and machine learning technologies for the analysis of medical data, prediction generation, assistance in diagnoses, or aiding healthcare professionals in decision-making processes. The medical device sector has witnessed various advantageous applications of artificial intelligence and machine learning, including data management, facilitation of remote surgical procedures, diagnostic and operational support, and contributions to clinical trials.
The primary components encompassed in AI/ML medical devices are hardware systems and software-as-a-medical device. Hardware constitutes the tangible elements of a system or the mechanisms used for storing and executing the written instructions embedded in the application's software. These devices find application across different clinical domains such as radiology, cardiology, hematology, among others, catering to diverse end-users, including hospitals and healthcare providers, patients, pharmaceutical and biotechnology companies, healthcare payers, and more.
The artificial intelligence or machine learning (AI/ML) medical device market consists of revenues earned by entities by providing treatment planning and personalization, predictive analytics, monitoring, and alert systems. The market value includes the value of related goods sold by the service provider or included within the service offering. The artificial intelligence or machine learning (AI/ML) medical device market also includes sales of smart wearable health monitors, medical imaging devices, and diagnostics devices. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 1-3 business days.
The artificial intelligence or machine learning (ai/ml) medical device market size is expected to see exponential growth in the next few years. It will grow to $26.46 billion in 2030 at a compound annual growth rate (CAGR) of 26.8%. The growth in the forecast period can be attributed to rising adoption of precision medicine, expansion of telehealth services, regulatory approvals for AI medical devices, demand for early disease detection, growth of value-based healthcare models. Major trends in the forecast period include ai-powered diagnostic imaging, clinical decision support systems, remote patient monitoring devices, predictive healthcare analytics, robotic-assisted medical procedures.
Growing investments in healthcare AI are anticipated to drive the expansion of the artificial intelligence and machine learning medical device market in the coming years. Healthcare AI refers to the use of artificial intelligence technologies within the healthcare sector to enhance diagnosis, treatment, service delivery, and overall patient care. Increased funding in healthcare AI is largely fueled by the ability of AI and ML to transform healthcare operations, improve clinical outcomes, and boost efficiency. For example, in March 2023, data from the Department of Health and Social Care, a UK-based government body, indicated that more than 300,000 patients benefited from $147.2 million (£123 million) invested across 86 AI technologies through three funding rounds. In addition, Mendelian, a UK-based digital health startup, received $1.7 million (£1.4 million) to support the development of an AI system aimed at identifying patients with undiagnosed rare conditions. Furthermore, Medtronic, a US-based medical device manufacturer, was granted $3.18 million (£2.5 million) to advance the development of its AI-powered medical device, GI Genius. As a result, rising investments in healthcare AI continue to accelerate the growth of the artificial intelligence and machine learning medical device market.
Leading companies operating in the artificial intelligence and machine learning medical device market are concentrating on the development of advanced technologies such as AI-driven performance insights to improve surgical accuracy, streamline clinical workflows, and enhance patient outcomes through data-supported decision-making. AI-driven Performance Insights refers to an advanced analytical system that utilizes artificial intelligence algorithms to evaluate surgical videos and produce practical insights aimed at improving surgical efficiency, performance, and training. For instance, in April 2024, Medtronic plc, an Ireland-based medical device company, introduced 14 new AI-driven Performance Insights algorithms along with Touch Surgery Live Stream technology to support laparoscopic and robotic-assisted surgeries. These innovations enable AI-powered post-operative analysis with in-depth evaluation of surgical techniques and provide real-time remote viewing to strengthen surgical education and collaboration, establishing a new standard in AI-enabled surgical performance.
In April 2024, GE HealthCare, a US-based medical technology and digital solutions provider, acquired MIM Software for an undisclosed sum. With this acquisition, GE HealthCare seeks to enhance its AI-driven imaging and workflow solutions across oncology, urology, neurology, and cardiology by incorporating MIM Software’s advanced image analysis and multi-modality processing technologies. MIM Software is a US-based medical imaging software company that develops artificial intelligence and machine learning-enabled solutions for image analysis, processing, and treatment planning.
Major companies operating in the artificial intelligence or machine learning (ai/ml) medical device market are General Electric; Medtronic PLC; Canon Inc.; Nvidia Corporation; Siemens Healthineers AG; Koninklijke Philips N.V.; Stryker Corporation; RadNet Inc.; ShanghAI United Imaging Healthcare Co. Ltd.; Tempus; DataRobot Inc.; DeepMind Technologies Limited; Paige AI Inc.; Aidoc Medical Ltd.; Butterfly Network Inc.; Aidoc Medical; CellaVision AB; Clarius Mobile Health Corp.; Subtle Medical Inc.; Owkin Inc.; Cleerly Inc.; Behold.ai; Viz.AI Inc.; Arterys Inc.; Caption Health; Enlitic Inc.; Hyperfine Inc.; Nanox AI Ltd.
North America was the largest region in the artificial intelligence machine learning (AI/ML) medical device market in 2025. The regions covered in the artificial intelligence or machine learning (ai/ml) medical device market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the artificial intelligence or machine learning (ai/ml) medical device market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Tariffs have moderately affected the AI or machine learning medical device market by increasing costs of imported sensors, imaging components, and advanced processing units. Diagnostic imaging and robotic-assisted devices are most impacted, particularly in asia-pacific manufacturing hubs. Higher device costs can limit adoption in cost-sensitive healthcare systems. However, tariffs are encouraging localized manufacturing and software-centric innovation. This shift is supporting supply chain resilience and long-term market sustainability.
The artificial intelligence or machine learning (ai/ml) medical device market research report is one of a series of new reports that provides artificial intelligence or machine learning (ai/ml) medical device market statistics, including artificial intelligence or machine learning (ai/ml) medical device industry global market size, regional shares, competitors with a artificial intelligence or machine learning (ai/ml) medical device market share, detailed artificial intelligence or machine learning (ai/ml) medical device market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence or machine learning (ai/ml) medical device industry. This artificial intelligence or machine learning (ai/ml) medical device market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
An AI/ML medical device, short for artificial intelligence or machine learning medical device, refers to a medical device that integrates artificial intelligence and machine learning technologies for the analysis of medical data, prediction generation, assistance in diagnoses, or aiding healthcare professionals in decision-making processes. The medical device sector has witnessed various advantageous applications of artificial intelligence and machine learning, including data management, facilitation of remote surgical procedures, diagnostic and operational support, and contributions to clinical trials.
The primary components encompassed in AI/ML medical devices are hardware systems and software-as-a-medical device. Hardware constitutes the tangible elements of a system or the mechanisms used for storing and executing the written instructions embedded in the application's software. These devices find application across different clinical domains such as radiology, cardiology, hematology, among others, catering to diverse end-users, including hospitals and healthcare providers, patients, pharmaceutical and biotechnology companies, healthcare payers, and more.
The artificial intelligence or machine learning (AI/ML) medical device market consists of revenues earned by entities by providing treatment planning and personalization, predictive analytics, monitoring, and alert systems. The market value includes the value of related goods sold by the service provider or included within the service offering. The artificial intelligence or machine learning (AI/ML) medical device market also includes sales of smart wearable health monitors, medical imaging devices, and diagnostics devices. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 1-3 business days.
Table of Contents
1. Executive Summary
2. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Characteristics
3. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Supply Chain Analysis
4. Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Trends and Strategies
5. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Analysis of End Use Industries
7. Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Strategic Analysis Framework, Current Market Size, Market Comparisons and Growth Rate Analysis
8. Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Total Addressable Market (TAM) Analysis for the Market
9. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Segmentation
10. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market, Industry Metrics by Country
11. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Regional and Country Analysis
12. Asia-Pacific Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
13. China Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
14. India Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
15. Japan Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
16. Australia Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
17. Indonesia Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
18. South Korea Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
19. Taiwan Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
20. South East Asia Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
21. Western Europe Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
22. UK Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
23. Germany Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
24. France Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
25. Italy Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
26. Spain Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
27. Eastern Europe Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
28. Russia Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
29. North America Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
30. USA Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
31. Canada Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
32. South America Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
33. Brazil Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
34. Middle East Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
35. Africa Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
37. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Competitive Landscape and Company Profiles
38. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Other Major and Innovative Companies
41. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market High Potential Countries, Segments and Strategies
42. Appendix
Executive Summary
Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Global Report 2026 provides strategists, marketers and senior management with the critical information they need to assess the market.This report focuses artificial intelligence or machine learning (ai/ml) medical device market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
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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, including technological disruption, regulatory shifts, and changing consumer preferences? 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, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
- The market characteristics section of the report defines and explains the market. This section also examines key products and services offered in the market, evaluates brand-level differentiation, compares product features, and highlights major innovation and product development trends.
- The supply chain analysis section provides an overview of the entire value chain, including key raw materials, resources, and supplier analysis. It also provides a list competitor at each level of the supply chain.
- The updated trends and strategies section analyses the shape of the market as it evolves and highlights emerging technology trends such as digital transformation, automation, sustainability initiatives, and AI-driven innovation. It suggests how companies can leverage these advancements to strengthen their market position and achieve competitive differentiation.
- The regulatory and investment landscape section provides an overview of the key regulatory frameworks, regularity bodies, associations, and government policies influencing the market. It also examines major investment flows, incentives, and funding trends shaping industry growth and innovation.
- The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
- The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.
- The total addressable market (TAM) analysis section defines and estimates the market potential compares it with the current market size, and provides strategic insights and growth opportunities based on this evaluation.
- The market attractiveness scoring section evaluates the market based on a quantitative scoring framework that considers growth potential, competitive dynamics, strategic fit, and risk profile. It also provides interpretive insights and strategic implications for decision-makers.
- Market segmentations break down the market into sub markets.
- The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth.
- Expanded geographical coverage includes Taiwan and Southeast Asia, reflecting recent supply chain realignments and manufacturing shifts in the region. This section analyzes how these markets are becoming increasingly important hubs in the global value chain.
- The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
- The company scoring matrix section evaluates and ranks leading companies based on a multi-parameter framework that includes market share or revenues, product innovation, and brand recognition.
Report Scope
Markets Covered:
1) By Product: System Or Hardware; Software-As-A Medical Devices2) By Clinical Area: Radiology; Cardiology; Hematology; Other Clinical Areas
3) By End-User: Hospitals And Healthcare Providers; Patients; Pharmaceuticals And Biotechnology Companies; Healthcare payers; Other End-Users
Subsegments:
1) By System Or Hardware: Diagnostic Imaging Systems; Surgical Robots; Monitoring Devices2) By Software-As-A-Medical Device: AI Diagnostic Software; Clinical Decision Support Systems; Predictive Analytics Platforms
Companies Mentioned: General Electric; Medtronic PLC; Canon Inc.; Nvidia Corporation; Siemens Healthineers AG; Koninklijke Philips N.V.; Stryker Corporation; RadNet Inc.; ShanghAI United Imaging Healthcare Co. Ltd.; Tempus; DataRobot Inc.; DeepMind Technologies Limited; Paige AI Inc.; Aidoc Medical Ltd.; Butterfly Network Inc.; Aidoc Medical; CellaVision AB; Clarius Mobile Health Corp.; Subtle Medical Inc.; Owkin Inc.; Cleerly Inc.; Behold.ai; Viz.AI Inc.; Arterys Inc.; Caption Health; Enlitic Inc.; Hyperfine Inc.; Nanox AI Ltd.
Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Taiwan; Russia; South Korea; UK; USA; Canada; Italy; Spain
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.
Data Segmentation: 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.
Delivery Format: Word, PDF or Interactive Report + Excel Dashboard
Added Benefits:
- Bi-Annual Data Update
- Customisation
- Expert Consultant Support
Companies Mentioned
The companies featured in this Artificial Intelligence or Machine Learning (AI/ML) Medical Device market report include:- General Electric
- Medtronic PLC
- Canon Inc.
- Nvidia Corporation
- Siemens Healthineers AG
- Koninklijke Philips N.V.
- Stryker Corporation
- RadNet Inc.
- ShanghAI United Imaging Healthcare Co. Ltd.
- Tempus
- DataRobot Inc.
- DeepMind Technologies Limited
- Paige AI Inc.
- Aidoc Medical Ltd.
- Butterfly Network Inc.
- Aidoc Medical
- CellaVision AB
- Clarius Mobile Health Corp.
- Subtle Medical Inc.
- Owkin Inc.
- Cleerly Inc.
- Behold.ai
- Viz.AI Inc.
- Arterys Inc.
- Caption Health
- Enlitic Inc.
- Hyperfine Inc.
- Nanox AI Ltd.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 250 |
| Published | February 2026 |
| Forecast Period | 2026 - 2030 |
| Estimated Market Value ( USD | $ 10.24 Billion |
| Forecasted Market Value ( USD | $ 26.46 Billion |
| Compound Annual Growth Rate | 26.8% |
| Regions Covered | Global |
| No. of Companies Mentioned | 28 |
