AI-enabled Medical Devices Market Size, Share & Trends Analysis Report By Component (Software, Hardware), By Technology (Machine Learning, NLP), By Therapeutic Area, By End Use, By Region, And Segment Forecasts, 2025 - 2033
Description
AI-Enabled Medical Devices Market Summary
The global AI-enabled medical devices market size was estimated at USD 13.67 billion in 2024 and is projected to reach USD 255.76 billion by 2033, growing at a CAGR of 38.5% from 2025 to 2033. Growing adoption of personalized and precision medicine, medical imaging and diagnostics advancements, and a supportive regulatory and reimbursement landscape contribute to market growth.
In addition, increasing healthcare digitalization and rising investments and industry collaborations are some other factors fueling market growth further. Personalized medicine drives the adoption of AI-enabled medical devices by enabling tailored healthcare based on individual genetics, environment, and lifestyle. By analyzing genomic data, imaging scans, and clinical records, AI systems deliver actionable insights for precision therapies. These technologies facilitate early disease detection, risk stratification, and treatment monitoring aligned with personalized medical protocols.
Furthermore, advanced predictive analytics empower clinicians to manage patient health, proactively improving clinical outcomes. For instance, in January 2025, Lunit received FDA 510(k) clearance for its Lunit SCOPE IO, an AI-powered tissue analysis software designed for immuno-oncology. The solution helps identify tumor-infiltrating lymphocytes (TILs) in cancer tissues, supporting precision immunotherapy decisions.
Moreover, the evolution of AI algorithms, including deep learning, natural language processing, and computer vision, propels AI medical device capabilities. Improved algorithm accuracy enhances diagnostic precision and reduces error rates. These technological improvements facilitate expanded applications, including AI-assisted imaging, predictive risk modeling, and automated patient monitoring. For instance, in June 2025, Clairity, Inc. became the first FDA-authorized AI platform for breast cancer prediction, receiving De Novo authorization for CLAIRITY BREAST. This innovative platform predicts a woman’s five-year risk of developing breast cancer using only routine screening mammograms.
Global AI-enabled Medical Devices Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global AI-enabled medical devices market report based on component, technology, therapeutic area, end use, and region:
The global AI-enabled medical devices market size was estimated at USD 13.67 billion in 2024 and is projected to reach USD 255.76 billion by 2033, growing at a CAGR of 38.5% from 2025 to 2033. Growing adoption of personalized and precision medicine, medical imaging and diagnostics advancements, and a supportive regulatory and reimbursement landscape contribute to market growth.
In addition, increasing healthcare digitalization and rising investments and industry collaborations are some other factors fueling market growth further. Personalized medicine drives the adoption of AI-enabled medical devices by enabling tailored healthcare based on individual genetics, environment, and lifestyle. By analyzing genomic data, imaging scans, and clinical records, AI systems deliver actionable insights for precision therapies. These technologies facilitate early disease detection, risk stratification, and treatment monitoring aligned with personalized medical protocols.
Furthermore, advanced predictive analytics empower clinicians to manage patient health, proactively improving clinical outcomes. For instance, in January 2025, Lunit received FDA 510(k) clearance for its Lunit SCOPE IO, an AI-powered tissue analysis software designed for immuno-oncology. The solution helps identify tumor-infiltrating lymphocytes (TILs) in cancer tissues, supporting precision immunotherapy decisions.
Moreover, the evolution of AI algorithms, including deep learning, natural language processing, and computer vision, propels AI medical device capabilities. Improved algorithm accuracy enhances diagnostic precision and reduces error rates. These technological improvements facilitate expanded applications, including AI-assisted imaging, predictive risk modeling, and automated patient monitoring. For instance, in June 2025, Clairity, Inc. became the first FDA-authorized AI platform for breast cancer prediction, receiving De Novo authorization for CLAIRITY BREAST. This innovative platform predicts a woman’s five-year risk of developing breast cancer using only routine screening mammograms.
Global AI-enabled Medical Devices Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global AI-enabled medical devices market report based on component, technology, therapeutic area, end use, and region:
- Component Outlook (Revenue, USD Million, 2021 - 2033)
- Software
- Hardware
- AI-enabled Medical Devices
- Smart Wearables
- Services
- Technology Outlook (Revenue, USD Million, 2021 - 2033)
- Machine Learning
- Deep learning
- Supervised
- Unsupervised
- Others
- Natural Language Processing (NLP)
- Computer Vision
- Context-Aware Computing
- Therapeutic Area Outlook (Revenue, USD Million, 2021 - 2033)
- Cardiology
- Neurology
- Radiology
- Oncology
- Mental and Behavioral Health
- Ophthalmology
- Others
- End Use Outlook (Revenue, USD Million, 2021 - 2033)
- Hospitals & Clinics
- Diagnostic Centers
- Ambulatory Surgical Centers (ASCs)
- Home Care Settings
- Others
- Regional Outlook (Revenue, USD Million, 2021 - 2033)
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- UK
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
- Asia Pacific
- China
- Japan
- India
- South Korea
- Australia
- Thailand
- Latin America
- Brazil
- Argentina
- MEA
- South Africa
- Saudi Arabia
- UAE
- Kuwait
Table of Contents
100 Pages
- Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Market Definitions
- 1.2.1. Component Segment
- 1.2.2. Technology Segment
- 1.2.3. Therapeutic Area Segment
- 1.2.4. End Use Segment
- 1.3. Information analysis
- 1.3.1. Market formulation & data visualization
- 1.4. Data validation & publishing
- 1.5. Information Procurement
- 1.5.1. Primary Research
- 1.6. Information or Data Analysis
- 1.7. Market Formulation & Validation
- 1.8. Market Model
- 1.9. Total Market: CAGR Calculation
- 1.10. Objectives
- 1.10.1. Objective 1
- 1.10.2. Objective 2
- Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Snapshot
- 2.3. Competitive Insights Landscape
- Chapter 3. AI-Enabled Medical Devices Market Variables, Trends & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent market outlook
- 3.1.2. Related/ancillary market outlook.
- 3.2. Market Dynamics
- 3.2.1. Market driver analysis
- 3.2.1.1. Rising demand for early disease diagnosis and predictive healthcare
- 3.2.1.2. Increasing adoption of personalized medicine and precision healthcare approaches.
- 3.2.1.3. Growing use of wearables and remote patient monitoring devices.
- 3.2.1.4. Advancements in machine learning, deep learning, and big data analytics enabling smarter devices.
- 3.2.2. Market restraint analysis
- 3.2.2.1. Data security and privacy concerns
- 3.2.2.2. High costs of advanced devices
- 3.2.3. Market opportunity analysis
- 3.2.4. Market challenges analysis
- 3.3. AI-Enabled Medical Devices Market Analysis Tools
- 3.3.1. Industry Analysis - Porter’s
- 3.3.1.1. Supplier power
- 3.3.1.2. Buyer power
- 3.3.1.3. Substitution threat
- 3.3.1.4. Threat of new entrant
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political landscape
- 3.3.2.2. Technological landscape
- 3.3.2.3. Economic landscape
- 3.3.2.4. Environmental Landscape
- 3.3.2.5. Legal Landscape
- 3.3.2.6. Social Landscape
- Chapter 4. AI-Enabled Medical Devices Market: Component Estimates & Trend Analysis
- 4.1. Segment Dashboard
- 4.2. Global AI-Enabled Medical Devices Market Component Movement Analysis
- 4.3. Global AI-Enabled Medical Devices Market Size & Trend Analysis, by Component, 2021 - 2033 (USD Million)
- 4.4. Software
- 4.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 4.5. Hardware
- 4.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 4.5.2. AI-enabled Medical Devices
- 4.5.2.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 4.5.3. Smart Wearables
- 4.5.3.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 4.6. Services
- 4.6.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- Chapter 5. AI-Enabled Medical Devices Market: Technology Estimates & Trend Analysis
- 5.1. Segment Dashboard
- 5.2. Global AI-Enabled Medical Devices Market Technology Movement Analysis
- 5.3. Global AI-Enabled Medical Devices Market Size & Trend Analysis, by Technology, 2021 - 2033 (USD Million)
- 5.4. Machine Learning Algorithms
- 5.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 5.4.2. Deep learning
- 5.4.2.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 5.4.3. Supervised
- 5.4.3.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 5.4.4. Unsupervised
- 5.4.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 5.4.5. Others
- 5.4.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 5.5. Natural Language Processing (NLP)
- 5.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 5.6. Computer Vision Techniques
- 5.6.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 5.7. Context-Aware Computing
- 5.7.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- Chapter 6. AI-Enabled Medical Devices Market: Therapeutic Area Estimates & Trend Analysis
- 6.1. Segment Dashboard
- 6.2. Global AI-enabled Medical Devices Market Therapeutic Area Movement Analysis
- 6.3. Global AI-enabled Medical Devices Market Size & Trend Analysis, by Therapeutic Area, 2021 - 2033 (USD Million)
- 6.4. Cardiology
- 6.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 6.5. Neurology
- 6.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 6.6. Radiology
- 6.6.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 6.7. Oncology
- 6.7.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 6.8. Mental and Behavioral Health
- 6.8.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 6.9. Ophthalmology
- 6.9.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 6.10. Others
- 6.10.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- Chapter 7. AI-Enabled Medical Devices Market: End Use Estimates & Trend Analysis
- 7.1. Segment Dashboard
- 7.2. Global AI-Enabled Medical Devices Market End Use Movement Analysis
- 7.3. Global AI-Enabled Medical Devices Market Size & Trend Analysis, by End Use, 2021 - 2033 (USD Million)
- 7.4. Hospitals & Clinics
- 7.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5. Diagnostic Centers
- 7.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6. Ambulatory Surgical Centers (ASCs)
- 7.6.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.7. Home Care Settings
- 7.7.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.8. Others
- 7.8.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
- Chapter 8. AI-Enabled Medical Devices Market: Regional Estimates & Trend Analysis
- 8.1. Regional Market Share Analysis, 2024 & 2033
- 8.2. Regional Market Dashboard
- 8.3. Market Size & Forecasts Trend Analysis, 2021 - 2033:
- 8.4. North America
- 8.4.1. U.S.
- 8.4.1.1. Key country dynamics
- 8.4.1.2. Regulatory framework
- 8.4.1.3. Competitive scenario
- 8.4.1.4. U.S. market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.4.2. Canada
- 8.4.2.1. Key country dynamics
- 8.4.2.2. Regulatory framework
- 8.4.2.3. Competitive scenario
- 8.4.2.4. Canada market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.4.3. Mexico
- 8.4.3.1. Key country dynamics
- 8.4.3.2. Regulatory framework
- 8.4.3.3. Competitive scenario
- 8.4.3.4. Mexico market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.5. Europe
- 8.5.1. UK
- 8.5.1.1. Key country dynamics
- 8.5.1.2. Regulatory framework
- 8.5.1.3. Competitive scenario
- 8.5.1.4. UK market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.5.2. Germany
- 8.5.2.1. Key country dynamics
- 8.5.2.2. Regulatory framework
- 8.5.2.3. Competitive scenario
- 8.5.2.4. Germany market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.5.3. France
- 8.5.3.1. Key country dynamics
- 8.5.3.2. Regulatory framework
- 8.5.3.3. Competitive scenario
- 8.5.3.4. France market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.5.4. Italy
- 8.5.4.1. Key country dynamics
- 8.5.4.2. Regulatory framework
- 8.5.4.3. Competitive scenario
- 8.5.4.4. Italy market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.5.5. Spain
- 8.5.5.1. Key country dynamics
- 8.5.5.2. Regulatory framework
- 8.5.5.3. Competitive scenario
- 8.5.5.4. Spain market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.5.6. Norway
- 8.5.6.1. Key country dynamics
- 8.5.6.2. Regulatory framework
- 8.5.6.3. Competitive scenario
- 8.5.6.4. Norway market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.5.7. Sweden
- 8.5.7.1. Key country dynamics
- 8.5.7.2. Regulatory framework
- 8.5.7.3. Competitive scenario
- 8.5.7.4. Sweden market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.5.8. Denmark
- 8.5.8.1. Key country dynamics
- 8.5.8.2. Regulatory framework
- 8.5.8.3. Competitive scenario
- 8.5.8.4. Denmark market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.6. Asia Pacific
- 8.6.1. Japan
- 8.6.1.1. Key country dynamics
- 8.6.1.2. Regulatory framework
- 8.6.1.3. Competitive scenario
- 8.6.1.4. Japan market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.6.2. China
- 8.6.2.1. Key country dynamics
- 8.6.2.2. Regulatory framework
- 8.6.2.3. Competitive scenario
- 8.6.2.4. China market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.6.3. India
- 8.6.3.1. Key country dynamics
- 8.6.3.2. Regulatory framework
- 8.6.3.3. Competitive scenario
- 8.6.3.4. India market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.6.4. Australia
- 8.6.4.1. Key country dynamics
- 8.6.4.2. Regulatory framework
- 8.6.4.3. Competitive scenario
- 8.6.4.4. Australia market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.6.5. South Korea
- 8.6.5.1. Key country dynamics
- 8.6.5.2. Regulatory framework
- 8.6.5.3. Competitive scenario
- 8.6.5.4. South Korea market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.6.6. Thailand
- 8.6.6.1. Key country dynamics
- 8.6.6.2. Regulatory framework
- 8.6.6.3. Competitive scenario
- 8.6.6.4. Thailand market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.7. Latin America
- 8.7.1. Brazil
- 8.7.1.1. Key country dynamics
- 8.7.1.2. Regulatory framework
- 8.7.1.3. Competitive scenario
- 8.7.1.4. Brazil market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.7.2. Argentina
- 8.7.2.1. Key country dynamics
- 8.7.2.2. Regulatory framework
- 8.7.2.3. Competitive scenario
- 8.7.2.4. Argentina market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.8. MEA
- 8.8.1. South Africa
- 8.8.1.1. Key country dynamics
- 8.8.1.2. Regulatory framework
- 8.8.1.3. Competitive scenario
- 8.8.1.4. South Africa market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.8.2. Saudi Arabia
- 8.8.2.1. Key country dynamics
- 8.8.2.2. Regulatory framework
- 8.8.2.3. Competitive scenario
- 8.8.2.4. Saudi Arabia market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.8.3. UAE
- 8.8.3.1. Key country dynamics
- 8.8.3.2. Regulatory framework
- 8.8.3.3. Competitive scenario
- 8.8.3.4. UAE market estimates and forecasts, 2021 - 2033 (USD Million)
- 8.8.4. Kuwait
- 8.8.4.1. Key country dynamics
- 8.8.4.2. Regulatory framework
- 8.8.4.3. Competitive scenario
- 8.8.4.4. Kuwait market estimates and forecasts, 2021 - 2033 (USD Million)
- Chapter 9. Competitive Landscape
- 9.1. Company/Competition Categorization
- 9.2. Strategy Mapping
- 9.3. Company Market Position Analysis, 2024
- 9.4. Company Profiles/Listing
- 9.4.1. Siemens Healthineers
- 9.4.1.1. Company overview
- 9.4.1.2. Financial performance
- 9.4.1.3. Product benchmarking
- 9.4.1.4. Strategic initiatives
- 9.4.2. GE Healthcare
- 9.4.2.1. Company overview
- 9.4.2.2. Financial performance
- 9.4.2.3. Product benchmarking
- 9.4.2.4. Strategic initiatives
- 9.4.3. Philips Healthcare
- 9.4.3.1. Company overview
- 9.4.3.2. Financial performance
- 9.4.3.3. Product benchmarking
- 9.4.3.4. Strategic initiatives
- 9.4.4. Medtronic
- 9.4.4.1. Company overview
- 9.4.4.2. Financial performance
- 9.4.4.3. Product benchmarking
- 9.4.4.4. Strategic initiatives
- 9.4.5. Johnson & Johnson (Ethicon)
- 9.4.5.1. Company overview
- 9.4.5.2. Financial performance
- 9.4.5.3. Product benchmarking
- 9.4.5.4. Strategic initiatives
- 9.4.6. Stryker
- 9.4.6.1. Company overview
- 9.4.6.2. Financial performance
- 9.4.6.3. Product benchmarking
- 9.4.6.4. Strategic initiatives
- 9.4.7. Canon Medical Systems
- 9.4.7.1. Company overview
- 9.4.7.2. Financial performance
- 9.4.7.3. Product benchmarking
- 9.4.7.4. Strategic initiatives
- 9.4.8. Zimmer Biomet
- 9.4.8.1. Company overview
- 9.4.8.2. Financial performance
- 9.4.8.3. Product benchmarking
- 9.4.8.4. Strategic initiatives
- 9.4.9. Abbott Laboratories
- 9.4.9.1. Company overview
- 9.4.9.2. Financial performance
- 9.4.9.3. Product benchmarking
- 9.4.9.4. Strategic initiatives
- 9.4.10. Boston Scientific
- 9.4.10.1. Company overview
- 9.4.10.2. Financial performance
- 9.4.10.3. Product benchmarking
- 9.4.10.4. Strategic initiatives
- 9.4.11. Exo Imaging, Inc.
- 9.4.11.1. Company overview
- 9.4.11.2. Financial performance
- 9.4.11.3. Product benchmarking
- 9.4.11.4. Strategic initiatives
- 9.4.12. Empatica
- 9.4.12.1. Company overview
- 9.4.12.2. Financial performance
- 9.4.12.3. Product benchmarking
- 9.4.12.4. Strategic initiatives
- 9.4.13. Aidoc
- 9.4.13.1. Company overview
- 9.4.13.2. Financial performance
- 9.4.13.3. Product benchmarking
- 9.4.13.4. Strategic initiatives
- 9.4.14. Clew Medical
- 9.4.14.1. Company overview
- 9.4.14.2. Financial performance
- 9.4.14.3. Product benchmarking
- 9.4.14.4. Strategic initiatives
- 9.4.15. Eko Health
- 9.4.15.1. Company overview
- 9.4.15.2. Financial performance
- 9.4.15.3. Product benchmarking
- 9.4.15.4. Strategic initiatives
- 9.4.16. Paige AI, Inc.
- 9.4.16.1. Company overview
- 9.4.16.2. Financial performance
- 9.4.16.3. Product benchmarking
- 9.4.16.4. Strategic initiatives
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