The artificial intelligence or machine learning (AI/ML) medical device market size has grown exponentially in recent years. It will grow from $6.63 billion in 2024 to $8.17 billion in 2025 at a compound annual growth rate (CAGR) of 23.2%. The growth in the historic period can be attributed to regulatory support, rise in chronic diseases, data accessibility, improvements in computational power, cost efficiency.
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 $21.07 billion in 2029 at a compound annual growth rate (CAGR) of 26.7%. The growth in the forecast period can be attributed to increased personalization, remote monitoring and telemedicine, ai/ml integrated diagnostics, patient-centric care, ai/ml in proactive care. Major trends in the forecast period include ai/ml-enhanced imaging devices, wearable ai/ml devices, ai/ml-powered prosthetics and robotics, point-of-care ai/ml diagnostics, ethical ai/ml use.
Investments in healthcare AI are poised to drive the growth of the artificial intelligence or machine learning medical device market in the future. Healthcare AI involves the application of AI technologies in the healthcare sector to enhance healthcare delivery, diagnostics, treatment, and overall patient care. The surge in investments in AI healthcare is fueled by the transformative potential of AI and ML technologies in revolutionizing healthcare delivery, improving patient outcomes, and increasing operational efficiency. For instance, as of March 2023, the UK Department of Health and Social Care reported that over 300,000 patients benefited from a total investment of $147.2 million (£123 million) across 86 AI technologies in three rounds of awards. Notably, Mendelian, a UK-based digital health startup, received $1.7 million (£1.4 million) for an AI system identifying patients with undiagnosed rare diseases. Additionally, Medtronic, a US-based medical device company, secured $3.18 million (£2.5 million) for the development of GI Genius, an AI-based medical device. Hence, healthcare AI investments are propelling the growth of the artificial intelligence and machine learning medical device market.
The increasing prevalence of wearable devices is anticipated to boost the growth of the artificial intelligence and machine learning medical device market in the future. Wearable devices are electronic gadgets that can be worn on the body, often as accessories or integrated into clothing, and come equipped with sensors, processors, and connectivity features. Wearable AI and ML devices are used for monitoring vital signs, activity levels, and other health metrics, and are becoming increasingly popular. These devices facilitate continuous health monitoring and support preventive healthcare practices. For example, in June 2022, the Australasian Society of Lifestyle Medicine, a not-for-profit organization based in Australia, reported that approximately 500 million smartwatches had been shipped globally, with annual sales expected to surpass 250 million units by 2025. Consequently, the rising number of wearable devices is driving the growth of the artificial intelligence and machine learning medical device market.
Technological advancements are a significant trend gaining traction in the artificial intelligence and machine learning medical device market. Major companies in this field are focusing on developing innovative technologies to maintain their competitive edge. For example, in April 2024, Medtronic plc, a medical device company based in Ireland, announced the introduction of 14 new AI-driven Performance Insights algorithms and Touch Surgery Live Stream technology, aimed at enhancing laparoscopic and robotic-assisted surgical procedures. These innovations enable AI-based post-operative analysis, delivering detailed insights into surgical techniques, and providing real-time, remote observation to improve surgical training and education, thus establishing a new standard for surgical performance and connectivity. This launch expands the role of AI in surgery, streamlining workflows and enabling surgeons to continually enhance their skills through actionable insights.
Major companies in the artificial intelligence or machine learning medical device market are also engaging in strategic partnerships to develop new products and reinforce their market positions. Strategic partnerships involve collaboration between companies to leverage each other’s strengths and resources for mutual benefits. In March 2023, NVIDIA, a US-based healthcare software company, partnered with Medtronic plc, an Ireland-based healthcare company, to introduce ‘NVIDIA Holoscan’ and ‘NVIDIA IGX.’ This collaboration focuses on integrating NVIDIA technology into Medtronic's real-time AI endoscopy device, enhancing patient care and improving outcomes. The partnership involves the integration of NVIDIA healthcare and edge AI technologies into the GI Genius intelligent endoscopy module, a product developed and manufactured by Cosmo Pharmaceuticals for Medtronic.
In October 2022, Exo Imaging Inc., a US-based provider of medical devices and health information, acquired Medo AI for an undisclosed amount. Through this acquisition, Exo aims to make ultrasound imaging more accessible and user-friendly, simplifying the process for caregivers to obtain and interpret ultrasound images. Medo AI, a Canadian company, specializes in AI-based medical devices.
Major companies operating in the artificial intelligence or machine learning (AI/ML) medical device market 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, H2O.ai, Clarius Mobile Health Corp., Subtle Medical Inc., Owkin Inc., Cleerly Inc., Behold.ai, Viz.ai Inc., Arterys Inc., Caption Health, Komodo Health Inc., Enlitic Inc., CloudMedx Inc., Hyperfine Inc., Nanox AI Ltd.
North America was the largest region in the artificial intelligence machine learning medical device market in 2024. The regions covered in the artificial intelligence or machine learning (ai/ml) medical device market report are Asia-Pacific, 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, Russia, South Korea, UK, USA, Italy, Spain, Canada.
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 machine learning medical device market research report is one of a series of new reports that provides artificial intelligence machine learning medical device market statistics, including the artificial intelligence machine learning medical device industry's global market size, regional shares, competitors with artificial intelligence machine learning medical device market share, detailed artificial intelligence machine learning medical device market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence machine learning medical device industry. This artificial intelligence machine learning medical device market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
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 3-5 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 $21.07 billion in 2029 at a compound annual growth rate (CAGR) of 26.7%. The growth in the forecast period can be attributed to increased personalization, remote monitoring and telemedicine, ai/ml integrated diagnostics, patient-centric care, ai/ml in proactive care. Major trends in the forecast period include ai/ml-enhanced imaging devices, wearable ai/ml devices, ai/ml-powered prosthetics and robotics, point-of-care ai/ml diagnostics, ethical ai/ml use.
Investments in healthcare AI are poised to drive the growth of the artificial intelligence or machine learning medical device market in the future. Healthcare AI involves the application of AI technologies in the healthcare sector to enhance healthcare delivery, diagnostics, treatment, and overall patient care. The surge in investments in AI healthcare is fueled by the transformative potential of AI and ML technologies in revolutionizing healthcare delivery, improving patient outcomes, and increasing operational efficiency. For instance, as of March 2023, the UK Department of Health and Social Care reported that over 300,000 patients benefited from a total investment of $147.2 million (£123 million) across 86 AI technologies in three rounds of awards. Notably, Mendelian, a UK-based digital health startup, received $1.7 million (£1.4 million) for an AI system identifying patients with undiagnosed rare diseases. Additionally, Medtronic, a US-based medical device company, secured $3.18 million (£2.5 million) for the development of GI Genius, an AI-based medical device. Hence, healthcare AI investments are propelling the growth of the artificial intelligence and machine learning medical device market.
The increasing prevalence of wearable devices is anticipated to boost the growth of the artificial intelligence and machine learning medical device market in the future. Wearable devices are electronic gadgets that can be worn on the body, often as accessories or integrated into clothing, and come equipped with sensors, processors, and connectivity features. Wearable AI and ML devices are used for monitoring vital signs, activity levels, and other health metrics, and are becoming increasingly popular. These devices facilitate continuous health monitoring and support preventive healthcare practices. For example, in June 2022, the Australasian Society of Lifestyle Medicine, a not-for-profit organization based in Australia, reported that approximately 500 million smartwatches had been shipped globally, with annual sales expected to surpass 250 million units by 2025. Consequently, the rising number of wearable devices is driving the growth of the artificial intelligence and machine learning medical device market.
Technological advancements are a significant trend gaining traction in the artificial intelligence and machine learning medical device market. Major companies in this field are focusing on developing innovative technologies to maintain their competitive edge. For example, in April 2024, Medtronic plc, a medical device company based in Ireland, announced the introduction of 14 new AI-driven Performance Insights algorithms and Touch Surgery Live Stream technology, aimed at enhancing laparoscopic and robotic-assisted surgical procedures. These innovations enable AI-based post-operative analysis, delivering detailed insights into surgical techniques, and providing real-time, remote observation to improve surgical training and education, thus establishing a new standard for surgical performance and connectivity. This launch expands the role of AI in surgery, streamlining workflows and enabling surgeons to continually enhance their skills through actionable insights.
Major companies in the artificial intelligence or machine learning medical device market are also engaging in strategic partnerships to develop new products and reinforce their market positions. Strategic partnerships involve collaboration between companies to leverage each other’s strengths and resources for mutual benefits. In March 2023, NVIDIA, a US-based healthcare software company, partnered with Medtronic plc, an Ireland-based healthcare company, to introduce ‘NVIDIA Holoscan’ and ‘NVIDIA IGX.’ This collaboration focuses on integrating NVIDIA technology into Medtronic's real-time AI endoscopy device, enhancing patient care and improving outcomes. The partnership involves the integration of NVIDIA healthcare and edge AI technologies into the GI Genius intelligent endoscopy module, a product developed and manufactured by Cosmo Pharmaceuticals for Medtronic.
In October 2022, Exo Imaging Inc., a US-based provider of medical devices and health information, acquired Medo AI for an undisclosed amount. Through this acquisition, Exo aims to make ultrasound imaging more accessible and user-friendly, simplifying the process for caregivers to obtain and interpret ultrasound images. Medo AI, a Canadian company, specializes in AI-based medical devices.
Major companies operating in the artificial intelligence or machine learning (AI/ML) medical device market 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, H2O.ai, Clarius Mobile Health Corp., Subtle Medical Inc., Owkin Inc., Cleerly Inc., Behold.ai, Viz.ai Inc., Arterys Inc., Caption Health, Komodo Health Inc., Enlitic Inc., CloudMedx Inc., Hyperfine Inc., Nanox AI Ltd.
North America was the largest region in the artificial intelligence machine learning medical device market in 2024. The regions covered in the artificial intelligence or machine learning (ai/ml) medical device market report are Asia-Pacific, 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, Russia, South Korea, UK, USA, Italy, Spain, Canada.
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 machine learning medical device market research report is one of a series of new reports that provides artificial intelligence machine learning medical device market statistics, including the artificial intelligence machine learning medical device industry's global market size, regional shares, competitors with artificial intelligence machine learning medical device market share, detailed artificial intelligence machine learning medical device market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence machine learning medical device industry. This artificial intelligence machine learning medical device market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
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 3-5 business days.
Table of Contents
1. Executive Summary2. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Characteristics3. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Trends and Strategies4. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market - Macro Economic Scenario including the impact of Interest Rates, Inflation, Geopolitics and Covid and Recovery on the Market32. Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Competitive Benchmarking and Dashboard33. Key Mergers and Acquisitions in the Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market34. Recent Developments in the Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
5. Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Growth Analysis and Strategic Analysis Framework
6. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Segmentation
7. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Regional and Country Analysis
8. Asia-Pacific Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
9. China Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
10. India Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
11. Japan Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
12. Australia Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
13. Indonesia Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
14. South Korea Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
15. Western Europe Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
16. UK Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
17. Germany Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
18. France Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
19. Italy Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
20. Spain Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
21. Eastern Europe Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
22. Russia Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
23. North America Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
24. USA Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
25. Canada Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
26. South America Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
27. Brazil Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
28. Middle East Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
29. Africa Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market
30. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Competitive Landscape and Company Profiles
31. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market Other Major and Innovative Companies
35. Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market High Potential Countries, Segments and Strategies
36. Appendix
Executive Summary
Artificial Intelligence or Machine Learning (AI/ML) Medical Device Global Market Report 2025 provides strategists, marketers and senior management with the critical information they need to assess the market.This report focuses on 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? 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 historic and forecast market growth by geography.
- The market characteristics section of the report defines and explains the market.
- 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 forecasts are made after considering the major factors currently impacting the market. These include the Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.
- 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. It covers the growth trajectory of COVID-19 for all regions, key developed countries and major emerging markets.
- 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 trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.
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
Key Companies Mentioned: General Electric; Medtronic PLC; Canon Inc.; Nvidia Corporation; Siemens Healthineers AG
Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Russia; South Korea; UK; USA; Canada; Italy; Spain
Regions: Asia-Pacific; 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: PDF, Word and Excel Data Dashboard.
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
- H2O.ai
- Clarius Mobile Health Corp.
- Subtle Medical Inc.
- Owkin Inc.
- Cleerly Inc.
- Behold.ai
- Viz.ai Inc.
- Arterys Inc.
- Caption Health
- Komodo Health Inc.
- Enlitic Inc.
- CloudMedx Inc.
- Hyperfine Inc.
- Nanox AI Ltd.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | February 2025 |
| Forecast Period | 2025 - 2029 |
| Estimated Market Value ( USD | $ 8.17 Billion |
| Forecasted Market Value ( USD | $ 21.07 Billion |
| Compound Annual Growth Rate | 26.7% |
| Regions Covered | Global |
| No. of Companies Mentioned | 31 |
