Artificial Intelligence/Machine Learning Medical Device Market Size, Share & Trends Analysis Report By Product Type (System/Hardware, Software-as-a-Medical Device), Application (Radiology, Cardiology, Hematology) And Segment Forecasts, 2025-2034

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. 

Recent Developments:

• In Nov 2021, Nano-X Imaging Ltd announced merger with Zebra Medical Vision, Ltd. had been completed. This strategic merger complements Nanox's deep learning technology and Nanox's product line.ARC System helps the company realize its vision of democratizing healthcare worldwide. This acquisition is another step towards the company's goal of democratising healthcare delivery. Nanox integrates AI-driven image analysis and a global teleradiology solution. The ARC technology brings company one step closer to a global, connected medical imaging solution with the potential to expand healthcare delivery significantly. 

Competitive Landscape:

Some of the Artificial Intelligence/Machine Learning Medical Device Market players are:

• CellaVision AB;
• Canon Inc.;
• Clarius Mobile Health Corp.
• General Electric Company;
• Aidoc Medical, Ltd.
• Koninklijke Philips N.V.,
• Hyperfine Inc.,
• Nanox.AI Ltd.,
• Medtronic Plc.,
• Page.AI,
• Koninklijke Philips N.V.
• Siemens Healthineers AG
• Tempus
• Shanghai United Imaging Healthcare Co., Ltd.
• Viz.ai, Inc.
• AI4MedImaging Medical Solutions S.A.
• Ever Fortune.AI Co., Ltd.
• MedMind Technology Co., Ltd.
• AIRS Medical Inc.
• CU-BX Automotive Technologies Ltd.
• Annalise-AI
• AZmed SAS
• Smart Soft Healthcare AD

Market Segmentation:

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 Radiology Sector Is Anticipated To Lead The Worldwide Artificial Intelligence/Machine Learning Medical Device Market (By Clinical Area)

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 held the largest market share in 2023

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.

Artificial Intelligence/Machine Learning Medical Device Market Report Scope:

Segmentation of Artificial Intelligence/Machine Learning Medical Device Market-

Artificial Intelligence/Machine Learning Medical Device Market By Product Type-

• System/Hardware
• Software-as-a-Medical Device 

Artificial Intelligence/Machine Learning Medical Device Market By Clinical Area-

• Radiology
• Diagnostic Assistance
• Imaging
• Image Reconstruction
• Cardiology
• Electrocardiography-Based Arrhythmia Detection
• Hemodynamics and Vital Signs Monitoring
• Hematology
• Others

By Region-

North America-

• The US
• Canada
• Mexico

Europe-

• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe

Asia-Pacific-

• China
• Japan
• India
• South Korea
• Southeast Asia
• Rest of Asia Pacific

Latin America-

• Brazil
• Argentina
• Rest of Latin America

 Middle East & Africa-

• GCC Countries
• South Africa
• Rest of Middle East and Africa