의료기기 인공지능(AI) 및 머신러닝(ML) 시장 : 기회 및 전략(-2035년)

Artificial intelligence or machine learning (AI/ML) medical devices refer to medical devices that incorporate artificial intelligence algorithms or machine learning models to perform medical functions such as diagnosis, prediction, monitoring, treatment planning, or therapeutic intervention. These devices may operate as standalone software applications or be embedded within physical medical equipment. They are used by healthcare professionals including physicians, radiologists, cardiologists, pathologists, laboratory technicians and nurses, as well as by patients in home-care settings. AI/ML medical devices are used during various stages of care, including screening, diagnosis, treatment planning, disease monitoring and post-treatment follow-up. They are increasingly deployed in both acute and chronic care management, enabling faster clinical decision-making and improved operational efficiency. Complementary products include traditional medical imaging systems, electronic health records (EHRs), clinical decision support systems, laboratory diagnostic equipment, wearable monitoring devices and telemedicine platforms. Substitute products include conventional non-AI-enabled medical devices and manual diagnostic interpretation performed solely by healthcare professionals without algorithmic assistance.

The global artificial intelligence or machine learning (AI/ML) medical device market was valued at $2,430.7 million in 2020 which grew till 2025 at a compound annual growth rate (CAGR) of more than 24.00%.

Shift To Home-Based Care

During the historic period, the artificial intelligence (AI) or machine learning (ML) medical device market was significantly driven by the shift to home-based care. As healthcare systems emphasized decentralized treatment models, chronic disease management increasingly moved outside hospital settings and demand for remote monitoring and continuous patient supervision grew, concerns related to hospital capacity constraints, rising healthcare costs and the need for real-time clinical insights intensified, leading to increased adoption of AI/ML-enabled medical devices designed to support remote diagnostics, predictive analytics, automated alerts and personalized care management across home and community-based settings. For example, according to the Centers for Disease Control and Prevention (CDC), a US-based government agency, there were approximately 11,500 home health agencies operating in the United States in 2022, of which 83.5% were for-profit organizations. In the same year, about 3.3 million patients received and ended home health care services. Therefore, the artificial intelligence (AI) or machine learning (ML) medical device market was significantly driven by the rising prevalence of the shift to home-based care during the historic period.

Artificial Intelligence & Autonomous Intelligence

Major companies in the artificial intelligence or machine learning (AI/ML) medical device market are increasingly prioritizing artificial intelligence (AI) and machine learning (ML) to enhance real-time diagnostic accuracy, automated clinical decision support and data-driven patient care optimization while reducing reliance on manual interpretation, traditional imaging protocols and isolated clinical assessments across medical devices and healthcare IT ecosystems. These AI/ML-enabled initiatives leverage advanced data integration, deep learning algorithms, predictive modeling and automated analytics to replace conventional rule-based diagnostic systems with self-optimizing digital architectures that continuously enhance detection precision, improve risk stratification and enable automated clinical recommendations while strengthening device reliability, interoperability and predictive outcome modeling across healthcare providers and hospital systems. For example, in April 2024, Prenosis Inc., a U.S.-based artificial intelligence company enabling precision medicine in acute care, announced FDA De Novo marketing authorization for its Sepsis ImmunoScore, an AI/machine learning software as a medical device designed for early diagnosis and risk prediction of sepsis. The system integrates biomarkers and clinical data to generate a risk score and four discrete risk categories, guiding clinicians in the emergency department or hospital to anticipate deterioration, length of stay, in-hospital mortality and escalation of care within 24 hours.

The global artificial intelligence or machine learning (AI/ML) medical device market is fairly fragmented, with a large number of small players operating in the market. The top 10 competitors in the market made up 10.17% of the total market in 2024.

Artificial Intelligence Or Machine Learning (AI/ML) Medical Devices Global Market Opportunities And Strategies To 2035 from The Business Research Company provides the strategists; marketers and senior management with the critical information they need to assess the global artificial intelligence or machine learning (AI/ML) medical devices market as it emerges from the COVID-19 shut down.

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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 from The Business Research Company 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 history and forecasts market growth by geography. It places the market within the context of the wider artificial intelligence or machine learning (AI/ML) medical device; and compares it with other markets.

The report covers the following chapters

• Introduction and Market Characteristics- Brief introduction to the segmentations covered in the market, definitions and explanations about the segments, key products, supply chain and market attractiveness scoring and analysis
• Key Trends- Highlights the major trends shaping the global market. This section also highlights likely future technologies and developments in the market.
• Growth Analysis And Strategic Analysis Framework Analysis on PESTEL, end use industries, market growth rate, global historic (2020-2025) and forecast (2025-2030, 2035F) market values and drivers and restraints that support and control the growth of the market in the historic and forecast periods, forecast growth contributors and total addressable market (TAM).
• Global Market Size And Growth Global historic (2020-2025) and forecast (2025-2030, 2035F) market values and drivers and restraints that support and control the growth of the market in the historic and forecast periods.
• Regional And Country Analysis- Historic (2020-2025) and forecast (2025-2030, 2035F) market values and growth and market share comparison by region and country.
• Market Segmentation- Contains the market values (2020-2025) (2025-2030, 2035F) and analysis for each segment by product, by clinical area and by end-user in the market. Historic (2020-2025) and forecast (2025-2030) and (2030-2035) market values and growth and market share comparison by region market.
• Regional Market Size and Growth- Regional market size (2025), historic (2020-2025) and forecast (2025-2030, 2035F) market values and growth and market share comparison of countries within the region. This report includes information on all the regions Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa and major countries within each region.
• Competitive Landscape- Details on the competitive landscape of the market, estimated market shares and company profiles of the leading players.
• Other Major And Innovative Companies- Details on the startups, company profiles of other major and innovative companies in the market.
• Competitive Benchmarking- Briefs on the financials comparison between major players in the market.
• Competitive Dashboard- Briefs on competitive dashboard of major players.
• Key Mergers and Acquisitions- Information on recent mergers and acquisitions in the market covered in the report. This section gives key financial details of mergers and acquisitions, which have shaped the market in recent years.
• Recent Developments- Information on recent developments in the market covered in the report.
• Market Opportunities And Strategies- Describes market opportunities and strategies based on findings of the research, with information on growth opportunities across countries, segments and strategies to be followed in those markets.
• Conclusions And Recommendations- This section includes recommendations for artificial intelligence or machine learning (AI/ML) medical device providers in terms of product/service offerings geographic expansion, marketing strategies and target groups.
• Appendix- This section includes details on the NAICS codes covered, abbreviations and currencies codes used in this report.

Markets Covered:

• 1) By Product: System Or Hardware; Software-As-A Medical Devices
• 2) By Clinical Area: Radiology; Cardiology; Hematology; Other Clinical Areas
• 3) By End User: Food; Beverages; Pharmaceuticals; Personal Care; Chemicals; Other End Users
• Companies Mentioned: Siemens Healthineers AG; GE Healthcare Technologies Inc.; Koninklijke Philips N.V.; Tempus AI Inc.; Canon Inc.
• Countries: China; Australia; India; Indonesia; Japan; South Korea; Taiwan; USA; Canada; Brazil; France; Germany; UK; Italy; Spain; Russia
• 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; artificial intelligence or machine learning (AI/ML) medical devices indicators comparison.
• Data segmentations: 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."

Table of Contents

1 Executive Summary

• 1.1 Dashboard

2 Table Of Contents

3 List Of Tables

4 List Of Figures

5 Report Structure

6 Market Characteristics

• 6.1 General Market Definition
• 6.2 Summary
• 6.3 Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Definition And Segmentations
• 6.4 Market Segmentation By Product (System Or Hardware And Software-As-A Medical Devices)
• 6.5 Market Segmentation By Clinical Area (Radiology, Cardiology, Hematology And Other Clinical Areas)
• 6.6 Market Segmentation By End-User (Hospitals And Healthcare Providers, Patients, Pharmaceuticals And Biotechnology Companies, Healthcare payers And Other End-Users)

7 Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Overview Of Key Products/Services

8 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Attractiveness Scoring And Analysis

• 8.1 Overview Of Market Attractiveness Framework
• 8.2 Quantitative Scoring Methodology
• 8.3 Market Attractiveness Scoring And Interpretation
• 8.4 Factor-Wise Evaluation
  • 8.4.1 Growth Potential
  • 8.4.2 Competitive Dynamics
  • 8.4.3 Strategic Fit
  • 8.4.4 Risk Profile
• 8.5 Strategic Implications And Recommendations
  • 8.5.1 Strategic Implications
  • 8.5.2 Strategic Recommendations

9 Major Market Trends

• 9.1 Key Technologies & Future Trends
  • 9.1.1 Artificial Intelligence & Autonomous Intelligence
  • 9.1.2 Digitalization, Cloud, Big Data & Cybersecurity
  • 9.1.3 Biotechnology, Genomics & Precision Medicine
  • 9.1.4 Industry 4.0 & Intelligent Manufacturing
  • 9.1.5 Internet of Things (IoT), Smart Infrastructure & Connected Ecosystems
• 9.2 Major Trends
  • 9.2.1 Innovation in clinician-in-the-loop AI supporting decision-making.
  • 9.2.2 Advancement in multi-modal AI enhancing diagnostic accuracy.
  • 9.2.3 Innovation in AI-driven quality assurance shortening validation cycles.
  • 9.2.4 Technology in edge AI enabling fast on-device intelligence

10 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Growth Analysis And Strategic Analysis Framework

• 10.1 Global Artificial Intelligence Or Machine Learning (AIML) Medical Device PESTEL Analysis (Political, Social, Technological, Environmental and Legal Factors)
  • 10.1.1 Political
  • 10.1.2 Economic
  • 10.1.3 Social
  • 10.1.4 Technological
  • 10.1.5 Environmental
  • 10.1.6 Legal
• 10.2 End-User (B2B) Analysis
  • 10.2.1 Hospitals And Healthcare Providers
  • 10.2.2 Patients
  • 10.2.3 Pharmaceuticals And Biotechnology Companies
  • 10.2.4 Healthcare Payers
  • 10.2.5 Other End-Users

11 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Size And Growth Analysis

• 11.1 Historic Market Growth, 2020 - 2025, Value ($ Million)
  • 11.1.1 Market Drivers 2020 - 2025
  • 11.1.2 Market Restraints 2020 - 2025
• 11.2 Forecast Market Growth, 2025 - 2030, 2035F Value ($ Million)
• 11.3 Forecast Growth Contributors/Factors
  • 11.3.1 Quantitative Growth Contributors
  • 11.3.2 Drivers
  • 11.3.3 Restraints

12 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Total Addressable Market (TAM) Analysis

• 12.1 Definition And Scope of Total Addressable Market (TAM)
• 12.2 Methodology And Assumptions
  • 12.2.1 Total Addressable Market for the Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market - Business to Customer (B2C)
  • 12.2.2 TAM Comparison Analysis

13 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Segmentation

• 13.1 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 13.2 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 13.3 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 13.4 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Sub-Segmentation Of System Or Hardware, By Type, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 13.5 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Sub-Segmentation Of Software-As-A Medical Devices, By Type, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)

14 Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Regional and Country Analysis

• 14.1 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, By Region, Historic and Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 14.2 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, By Country, Historic and Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)

15 Asia-Pacific Market

• 15.1 Asia-Pacific Market Summary
• 15.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 15.3 Asia-Pacific Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.4 Asia-Pacific Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.5 Asia-Pacific Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.6 China Market
  • 15.6.1 China Market Summary
  • 15.6.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 15.7 China Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.8 China Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.9 China Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.10 India Market
• 15.11 India Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.12 India Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.13 India Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.14 Japan Market
  • 15.14.1 Japan Market Summary
  • 15.14.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 15.15 Japan Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.16 Japan Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.17 Japan Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.18 Australia Market
• 15.19 Australia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.20 Australia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.21 Australia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.22 South Korea Market
  • 15.22.1 South Korea Market Summary
  • 15.22.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 15.23 South Korea Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.24 South Korea Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.25 South Korea Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.26 Taiwan Market
• 15.27 Taiwan Market Summary
  • 15.27.1 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 15.28 Taiwan Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.29 Taiwan Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 15.30 Taiwan Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)

16 South East Asia Market

• 16.1 South East Asia Market Summary
• 16.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
  • 16.2.1 South East Asia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
  • 16.2.2 South East Asia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
  • 16.2.3 South East Asia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 16.3 Indonesia Market
  • 16.3.1 Indonesia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
  • 16.3.2 Indonesia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
  • 16.3.3 Indonesia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)

17 North America Market

• 17.1 North America Market Summary
• 17.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 17.3 North America Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 17.4 North America Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 17.5 North America Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 17.6 USA Market
  • 17.6.1 USA Market Summary
  • 17.6.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 17.7 USA Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 17.8 USA Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 17.9 USA Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 17.10 Canada Market
  • 17.10.1 Canada Market Summary
  • 17.10.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 17.11 Canada Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 17.12 Canada Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 17.13 Canada Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)

18 Western Europe Market

• 18.1 Western Europe Market Summary
• 18.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 18.3 Western Europe Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.4 Western Europe Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.5 Western Europe Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.6 UK Market
• 18.7 UK Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.8 UK Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.9 UK Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.10 Germany Market
• 18.11 Germany Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.12 Germany Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.13 Germany Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.14 France Market
• 18.15 France Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.16 France Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.17 France Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.18 Italy Market
• 18.19 Italy Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.20 Italy Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.21 Italy Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.22 Spain Market
• 18.23 Spain Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.24 Spain Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 18.25 Spain Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)

19 South America Market

• 19.1 South America Market Summary
• 19.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 19.3 South America Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 19.4 South America Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 19.5 South America Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 19.6 Brazil Market
• 19.7 Brazil Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 19.8 Brazil Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 19.9 Brazil Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)

20 Eastern Europe Market

• 20.1 Eastern Europe Market Summary
• 20.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 20.3 Eastern Europe Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 20.4 Eastern Europe Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 20.5 Eastern Europe Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 20.6 Russia Market
• 20.7 Russia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 20.8 Russia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 20.9 Russia Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)

21 Middle East Market

• 21.1 Middle East Market Summary
• 21.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 21.3 Middle East Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 21.4 Middle East Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 21.5 Middle East Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)

22 Africa Market

• 22.1 Africa Market Summary
• 22.2 Market Overview (Region Information, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments And Major Companies)
• 22.3 Africa Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Product, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 22.4 Africa Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By Clinical Area, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)
• 22.5 Africa Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Segmentation By End-User, Historic And Forecast, 2020 - 2025, 2030F, 2035F, Value ($ Million)

23 Competitive Landscape And Company Profiles

• 23.1 Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market Competitive Landscape And Market Share 2024
  • 23.1.1 Top 10 Companies (Ranked by revenue/share)
• 23.2 Company Profiles
• 23.3 Siemens Healthineers (Company Overview, Products and Services, Business Strategy, Financial Overview)
• 23.4 GE Healthcare Technologies Inc (Company Overview, Products and Services, Business Strategy, Financial Overview)
• 23.5 Koninklijke Philips N.V (Company Overview, Products and Services, Business Strategy, Financial Overview)
• 23.6 Tempus AI Inc (Company Overview, Products and Services, Business Strategy, Financial Overview)
• 23.7 Canon Inc (Canon Medical Systems) (Company Overview, Products and Services, Business Strategy, Financial Overview)

24 Other Major And Innovative Companies

• 24.1 Fujifilm Holdings (Company Overview, Products and Services)
• 24.2 Medtronic plc (Company Overview, Products and Services)
• 24.3 Shanghai United Imaging Healthcare Co. Ltd. (Company Overview, Products and Services)
• 24.4 Aidoc Medical Ltd. (Company Overview, Products and Services)
• 24.5 Stryker Corp. (Company Overview, Products and Services)
• 24.6 PathAI Inc. (Company Overview, Products and Services)
• 24.7 Butterfly Network Inc. (Company Overview, Products and Services)
• 24.8 Qure.ai (Company Overview, Products and Services)
• 24.9 Paige AI Inc. (Company Overview, Products and Services)
• 24.10 Clarius Mobile Health Corp. (Company Overview, Products and Services)
• 24.11 Lunit (Company Overview, Products and Services)
• 24.12 Hyperfine Inc. (Company Overview, Products and Services)
• 24.13 Behold.ai Technologies Ltd. (Company Overview, Products and Services)
• 24.14 Viz.AI Inc. (Company Overview, Products and Services)
• 24.15 Subtle Medical Inc. (Company Overview, Products and Services)

25 Competitive Benchmarking

26 Competitive Dashboard

27 Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market - Company Scoring Matrix

• 27.1 Innovation and Brand Leaders
• 27.2 Brand-Driven Traditionalists
• 27.3 Niche or Regional Followers
• 27.4 Emerging Innovators

28 Upcoming Startups In the Market

29 Key Mergers and Acquisitions

• 29.1.1 Clario Acquired ArtiQ
• 29.1.2 Lunit Inc. Acquired Volpara Health Technologies Limited

30 Recent Developments in Artificial Intelligence or Machine Learning (AI/ML) Medical Device

• 30.1 Tempus Pixel Platform Gains Real-Time AI Lung Nodule Detection via Median Technologies' eyonis LCS
• 30.2 AI-Enabled Earpiece Set to Transform Epilepsy Monitoring and Patient Safety
• 30.3 ASUS Advances Precision Healthcare with AI Diagnostic and Imaging Devices
• 30.4 Olympus Unveils AI-Driven Endoscopy Devices, Paving Way for Intelligent Endoscopy Ecosystem in 2025

31 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Key Regulatory Trends

• 31.1 Shift To Lifecycle-Based Regulation
• 31.2 Predetermined Change Control Plans (PCCP)
• 31.3 Stronger Risk-Based Classification
• 31.4 Integration Of AI Regulations With Medical Device Rules
• 31.5 Focus On Good Machine Learning Practices (GMLP)
• 31.6 Greater Transparency And Explainability Rules
• 31.7 Stronger Post-Market Surveillance
• 31.8 Cybersecurity And Data Privacy Requirements
• 31.9 Regulation Of Generative AI And Digital Therapeutics

32 Opportunities And Strategies

• 32.1 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market In 2030 - Countries Offering Most New Opportunities
• 32.2 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market In 2030 - Segments Offering Most New Opportunities
• 32.3 Global Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market In 2030 - Growth Strategies
  • 32.3.1 Market Trend Based Strategies
  • 32.3.2 Competitor Strategies

33 Artificial Intelligence Or Machine Learning (AI/ML) Medical Device Market, Conclusions And Recommendations

• 33.1 Conclusions
• 33.2 Recommendations
  • 33.2.1 Product
  • 33.2.2 Place
  • 33.2.3 Price
  • 33.2.4 Promotion
  • 33.2.5 People

34 Appendix

• 34.1 Geographies Covered
• 34.2 Market Data Sources
• 34.3 Research Methodology
• 34.4 Currencies
• 34.5 The Business Research Company
• 34.6 Copyright and Disclaimer