The Artificial Intelligence/Machine Learning Medical Device Market Size is valued at 6.10 Billion in 2024 and is predicted to reach 52.09 Billion by the year 2031 at a 24.1% CAGR during the forecast period for 2024-2031.
The market for artificial intelligence/machine learning-enabled medical devices is very fragmented, and each year, more products bearing the FDA and CE marks are approved. Due to continuous technical advancements and investments in healthcare AI, this industry still has a substantial amount of growth potential. The advancement of AI-based medical devices that enable diagnostic accuracy and productivity present a potential opportunity for the worldwide artificial intelligence/machine learning medical device market.
The market is anticipated to develop quickly following the COVID-19 pandemic, mostly because of the increasing use of AI-based solutions brought on by the epidemic. The market will grow because of an increase in research into AI-enabled products, improvements in deep learning and machine learning algorithms, the release of new products onto the market, the emergence of regional businesses, and the expanding use of AI-based products for therapeutic purposes.
The Artificial Intelligence/Machine Learning Medical Device Market is segmented based on product type, clinical area. The product type segment includes System/Hardware and Software-as-a-Medical Device. By Clinical Area application, the market is divided into Radiology, Cardiology, and Hematology. The radiology segment it is segmented (by Type) includes Diagnostic Assistance, Imaging, and Image Reconstruction. The cardiology segment (by Type) includes Electrocardiography-Based Arrhythmia Detection and Hemodynamics and Vital Signs Monitoring.
The market for AI/ML medical devices will lead in the clinical area segment for radiology. AI-enabled medical devices are being developed for various clinical applications, including radiology, cardiology, hematology, obstetrics, gastrointestinal, and pathology. AI in radiology can support radiologists in data interpretation and diagnostic confirmation. For a variety of tasks in radiology, including the identification of suspicious lesions, improving the quality of imaging, picture segmentation and contouring, and image reconstruction, artificial intelligence (AI) is being used.
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America are the five geographic areas into which the worldwide market is divided. Significant R&D investors like Oracle Corporation, IBM Corporation, and Amazon.com increase the market size in the area. Furthermore, it is anticipated that substantial expenditures and the availability of existing IT infrastructure would fuel market expansion in North America.
Customers now have easier access to services and products that use AI, which impacts the regional economy. The European Union proposed a 10.4 billion USD budget for the Digital Europe Programme in June 2018 for the years 2021–2027. Over the course of the prediction, Asia Pacific is anticipated to advance at a speedier rate. A lively and robust startup ecosystem is present in the area's rising economies, including China, India, and the Philippines. An expanding trained labor force that fuels regional market expansion aids this ecosystem.
Report Attribute |
Specifications |
Market size value in 2024 |
USD 6.10 Bn |
Revenue forecast in 2034 |
USD 52.09 Bn |
Growth rate CAGR |
CAGR of 24.1% from 2025 to 2034 |
Quantitative units |
Representation of revenue in US$ Billion, and CAGR from 2024 to 2031 |
Historic Year |
2021 to 2024 |
Forecast Year |
2025-2034 |
Report coverage |
The forecast of revenue, the position of the company, the competitive market statistics, growth prospects, and trends |
Segments covered |
Product Type, Clinical Area |
Regional scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
Country scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; Japan; South Korea; Southeast Asia |
Competitive Landscape |
Aidoc Medical, Ltd., Canon Inc., CellaVision AB, Clarius Mobile Health Corp., General Electric Company, Hyperfine Inc., Koninklijke Philips N.V., Medtronic plc, Nanox.AI Ltd., Paige.AI |
Customization scope |
Free customization report with the procurement of the report, Modifications to the regional and segment scope. Particular Geographic competitive landscape. |
Pricing and available payment methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Artificial Intelligence/Machine Learning Medical Device Market Snapshot
Chapter 4. Global Artificial Intelligence/Machine Learning Medical Device Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Industry Analysis – Porter’s Five Forces Analysis
4.7. Competitive Landscape & Market Share Analysis
4.8. Impact of Covid-19 Analysis
Chapter 5. Market Segmentation 1: by Product Type Estimates & Trend Analysis
5.1. by Product Type & Market Share, 2024 & 2034
5.2. Market Size (Value (US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following by Product Type:
5.2.1. System/Hardware
5.2.2. Software-as-a-Medical Device
Chapter 6. Market Segmentation 2: by Clinical Area Estimates & Trend Analysis
6.1. by Clinical Area & Market Share, 2024 & 2034
6.2. Market Size (Value (US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following by Clinical Area:
6.2.1. Radiology
6.2.1.1. Diagnostic Assistance
6.2.1.2. Imaging
6.2.1.3. Image Reconstruction
6.2.1.4. Others
6.2.2. Cardiology
6.2.2.1. Electrocardiography-Based Arrhythmia Detection
6.2.2.2. Hemodynamics and Vital Signs Monitoring
6.2.2.3. Others
6.2.3. Hematology
6.2.4. Others
Chapter 7. Artificial Intelligence/Machine Learning Medical Device Market Segmentation 3: Regional Estimates & Trend Analysis
7.1. North America
7.1.1. North America Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Product Type, 2021-2034
7.1.2. North America Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Clinical Area, 2021-2034
7.1.3. North America Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
7.2. Europe
7.2.1. Europe Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Product Type, 2021-2034
7.2.2. Europe Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Clinical Area, 2021-2034
7.2.3. Europe Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
7.3. Asia Pacific
7.3.1. Asia Pacific Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Product Type, 2021-2034
7.3.2. Asia Pacific Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Clinical Area, 2021-2034
7.3.3. Asia Pacific Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
7.4. Latin America
7.4.1. Latin America Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Product Type, 2021-2034
7.4.2. Latin America Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Clinical Area, 2021-2034
7.4.3. Latin America Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
7.5. Middle East & Africa
7.5.1. Middle East & Africa Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Product Type, 2021-2034
7.5.2. Middle East & Africa Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by Clinical Area, 2021-2034
7.5.3. Middle East & Africa Artificial Intelligence/Machine Learning Medical Device Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
Chapter 8. Competitive Landscape
8.1. Major Mergers and Acquisitions/Strategic Alliances
8.2. Company Profiles
8.2.1. CellaVision AB;
8.2.2. Canon Inc.;
8.2.3. Clarius Mobile Health Corp.;
8.2.4. General Electric Company;
8.2.5. Aidoc Medical, Ltd.
8.2.6. Koninklijke Philips N.V.,
8.2.7. Hyperfine Inc.,
8.2.8. Nanox.AI Ltd.,
8.2.9. Medtronic Plc.,
8.2.10. Paige.AI, and Koninklijke
8.2.11. Philips N.V.
8.2.12. Siemens Healthineers AG
8.2.13. Tempus
8.2.14. Shanghai United Imaging Healthcare Co., Ltd.
8.2.15. Viz.ai, Inc.
8.2.16. AI4MedImaging Medical Solutions S.A.
8.2.17. Ever Fortune.AI Co., Ltd.
8.2.18. MedMind Technology Co., Ltd.
8.2.19. AIRS Medical Inc.
8.2.20. CU-BX Automotive Technologies Ltd.
8.2.21. Annalise-AI
8.2.22. AZmed SAS
8.2.23. Smart Soft Healthcare AD
8.2.24. Other Prominent Players
Artificial Intelligence/Machine Learning Medical Device Market By Product Type-
Artificial Intelligence/Machine Learning Medical Device Market By Clinical Area-
By Region-
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
To know more about the research methodology used for this study, kindly contact us/click here.