A quick peek into the report
Table of Contents
1.1 Global Market Outlook
1.1.1 Product Definition
1.1.2 Inclusion and Exclusion Criteria
1.1.3 Key Findings
1.1.4 Market Scenario
1.1.4.1 Realistic Growth Scenario
1.1.4.2 Optimistic Growth Scenario
1.1.4.3 Pessimistic/Conservative Growth Scenario
1.2 Industry Outlook
1.2.1 Market Overview
1.2.2 Key Trends
1.2.2.1 Updations of Government Regulations to Accommodate the Development and Regulation of AI-enabled SaMD
1.2.2.2 Most AI-Enabled Medical Devices Aid in Clinical Decision-Making but do not Provide the Final Diagnosis Themselves
1.2.2.3 Very Few AI-Enabled Medical Devices Have to Undergo the Rigorous PMA Process: Rest Get 510(k) Clearance
1.2.3 Opportunity Assessment
1.2.4 Business Models
1.2.5 Recommendations for Key Players
1.2.6 Patent Analysis
1.2.6.1 Awaited Technological Developments
1.2.6.2 Patent Filing Trend (by Country)
1.2.6.3 Patent Filing Trend (by Year)
1.2.7 Funding Scenario
1.2.8 Product Benchmarking
1.2.9 End User Perception
1.3 Impact of COVID-19 on the Global Artificial Intelligence/Machine Learning Medical Device
1.3.1 Pre-COVID-19 Phase
1.3.2 During COVID-19
1.3.2.1 Impact of COVID-19 on Clinical Settings and Clinical Decision-Making
1.3.3 Post-COVID-19 Phase
1.4 Business Dynamics
1.4.1 Impact Analysis
1.4.2 Business Drivers
1.4.2.1 Presence of a Large Ecosystem of Companies Offering AI Solutions Targeting the Diverse Range of Applications of AI in the Healthcare
1.4.2.2 Growing Demand in the Field of Radiology and Cardiology Increasing Adoption of AI-Enabled Solutions due to Their Ability to Shorten Waiting Times and Reduce Burden on Healthcare System
1.4.2.3 Growing Demand for Wearable Sensors to Increase Adoption of AI-Enabled Medical Devices for Home-Based Care
1.4.2.4 Large Number of Government Initiatives Advancing the Research and Development of AI-Enabled Medical Devices
1.4.3 Business Restraints
1.4.3.1 Lack of Transparency and Concerns around Data Sharing Leading to Cybersecurity Concerns and Hindering Adoption of AI in Healthcare
1.4.3.2 Challenges Related to Identification and Minimization of Bias in AI Algorithms Leading to Concerns Surrounding the Reliability of Diagnosis and Thus Hindering the Use of AI-Enabled Solutions
1.4.4 Business Opportunities
1.4.4.1 Applications across a Wide Range of Clinical Areas Present Opportunities for Further Research and Development
1.4.4.2 Potential of AI to Shorten Wait Times and Reduce Disease Burden on the Healthcare System, Especially in Low- and Middle-Income Countries (LMICs)
1.4.4.3 Increasing Number of Medical Imaging Equipment Coupled with Relatively Lower Adoption of AI-enabled Medical Devices Presents Opportunity for Growth in Regions such as Asia-Pacific
2.1 Opportunity Assessment
2.2 Growth-Share Matrix
2.3 System/Hardware
2.4 Software-as-a-Medical Device
3.1 Opportunity Assessment
3.2 Growth-Share Matrix
3.3 Radiology
3.3.1 Market Dynamics
3.3.2 Some Players in Radiology
3.3.3 Market Sizing and Forecast
3.3.3.1 By Type
3.3.3.1.1 Diagnostic Assistance
3.3.3.1.2 Imaging
3.3.3.1.3 Image Reconstruction
3.3.3.1.4 Others
3.4 Cardiology
3.4.1 Market Dynamics
3.4.2 Some Players in Cardiology
3.4.3 Market Sizing and Forecast
3.4.3.1 By Type
3.4.3.1.1 Electrocardiography-Based Arrhythmia Detection
3.4.3.1.2 Hemodynamics and Vital Signs Monitoring
3.4.3.1.3 Others
3.5 Hematology
3.5.1 Market Dynamics
3.5.2 Some Players in Hematology
3.5.3 Market Sizing and Forecast
3.6 Others
3.6.1 Market Dynamics
3.6.2 Some Players in Other Application Areas
3.6.3 Market Sizing and Forecast
4.1 North America Artificial Intelligence/Machine Learning Medical Device Market
4.1.1 Regulatory Framework
4.1.2 Technology Adoption
4.1.3 Key Findings and Opportunity Assessment
4.1.4 Market Dynamics
4.1.4.1 Impact Analysis
4.1.5 Market Sizing and Forecast
4.1.5.1 North America Artificial Intelligence/Machine Learning Medical Device Market (by Country)
4.1.5.1.1 U.S.
4.1.5.1.1.1 Market Dynamics
4.1.5.1.1.2 Market Size and Forecast
4.1.5.1.2 Canada
4.1.5.1.2.1 Market Dynamics
4.1.5.1.2.2 Market Size and Forecast
4.2 Europe Artificial Intelligence/Machine Learning Medical Device Market
4.2.1 Regulatory Framework
4.2.2 Technology Adoption
4.2.3 Key Findings and Opportunity Assessment
4.2.4 Market Dynamics
4.2.4.1 Impact Analysis
4.2.5 Market Sizing and Forecast
4.2.5.1 Europe Artificial Intelligence/Machine Learning Medical Device Market (by Country)
4.2.5.1.1 Germany
4.2.5.1.1.1 Market Dynamics
4.2.5.1.1.2 Market Size and Forecast
4.2.5.1.2 France
4.2.5.1.2.1 Market Dynamics
4.2.5.1.2.2 Market Size and Forecast
4.2.5.1.3 Italy
4.2.5.1.3.1 Market Dynamics
4.2.5.1.3.2 Market Size and Forecast
4.2.5.1.4 U.K.
4.2.5.1.4.1 Market Dynamics
4.2.5.1.4.2 Market Size and Forecast
4.2.5.1.5 Spain
4.2.5.1.5.1 Market Dynamics
4.2.5.1.5.2 Market Size and Forecast
4.2.5.1.6 Rest-of-Europe
4.2.5.1.6.1 Market Dynamics
4.2.5.1.6.2 Market Size and Forecast
4.3 Asia-Pacific Artificial Intelligence/Machine Learning Medical Device Market
4.3.1 Regulatory Framework
4.3.2 Technology Adoption
4.3.3 Key Findings and Opportunity Assessment
4.3.4 Market Dynamics
4.3.4.1 Impact Analysis
4.3.5 Market Size and Forecast
4.3.5.1 Asia-Pacific Artificial Intelligence/Machine Learning Medical Device Market (by Country)
4.3.5.1.1 Japan
4.3.5.1.1.1 Market Dynamics
4.3.5.1.1.2 Market Size and Forecast
4.3.5.1.2 China
4.3.5.1.2.1 Market Dynamics
4.3.5.1.2.2 Market Size and Forecast
4.3.5.1.3 Australia
4.3.5.1.3.1 Market Dynamics
4.3.5.1.3.2 Market Size and Forecast
4.3.5.1.4 South Korea
4.3.5.1.4.1 Market Dynamics
4.3.5.1.4.2 Market Size and Forecast
4.3.5.1.5 India
4.3.5.1.5.1 Market Dynamics
4.3.5.1.5.2 Market Size and Forecast
4.3.5.1.6 Rest-of-Asia-Pacific
4.3.5.1.6.1 Market Dynamics
4.3.5.1.6.2 Market Size and Forecast
4.4 Rest-of-the-World Artificial Intelligence/Machine Learning Medical Device Market
4.4.1 Regulatory Framework
4.4.2 Technology Adoption
4.4.3 Key Findings and Opportunity Assessment
4.4.4 Market Dynamics
4.4.4.1 Impact Analysis
4.4.5 Market Size and Forecast
4.4.5.1 Rest-of-the-World Artificial Intelligence/Machine Learning Medical Device Market (by Country)
4.4.5.1.1 Brazil
4.4.5.1.1.1 Market Dynamics
4.4.5.1.1.2 Market Size and Forecast
4.4.5.1.2 Mexico
4.4.5.1.2.1 Market Dynamics
4.4.5.1.2.2 Market Size and Forecast
4.4.5.1.3 Israel
4.4.5.1.3.1 Market Dynamics
4.4.5.1.3.2 Market Size and Forecast
4.4.5.1.4 Rest-of-Rest-of-the-World
4.4.5.1.4.1 Market Dynamics
4.4.5.1.4.2 Market Size and Forecast
5.1 Competitive Benchmarking
5.1.1 Key Strategies and Developments
5.1.1.1.1 Regulatory and Legal Activities
5.1.1.1.2 Funding Activities
5.1.1.1.3 New Offerings
5.1.1.1.4 Mergers and Acquisitions
5.1.1.1.5 Partnerships, Collaborations, and Business Expansions
5.2 Company Profiles
5.2.1 Aidoc Medical, Ltd.
5.2.1.1 Company Overview
5.2.1.2 Role of Aidoc Medical, Ltd. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.1.3 Key Developments
5.2.1.4 Analyst Perception
5.2.2 Canon Inc.
5.2.2.1 Company Overview
5.2.2.2 Role of Canon Inc. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.2.3 Financials
5.2.2.4 Analyst Perception
5.2.3 CellaVision AB
5.2.3.1 Company Overview
5.2.3.2 Role of CellaVision AB in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.3.3 Financials
5.2.3.4 Analyst Perception
5.2.4 Clarius Mobile Health Corp.
5.2.4.1 Company Overview
5.2.4.2 Role of Clarius Mobile Health Corp. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.4.3 Key Developments
5.2.4.4 Analyst Perception
5.2.5 General Electric Company
5.2.5.1 Company Overview
5.2.5.2 Role of General Electric Company in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.5.3 Financials
5.2.5.4 Analyst Perception
5.2.6 Hyperfine Inc.
5.2.6.1 Company Overview
5.2.6.2 Role of Hyperfine Inc. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.6.3 Financials
5.2.6.4 Key Developments
5.2.6.5 Analyst Perception
5.2.7 Koninklijke Philips N.V.
5.2.7.1 Company Overview
5.2.7.2 Role of Koninklijke Philips N.V. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.7.3 Financials
5.2.7.4 Key Developments
5.2.7.5 Analyst Perception
5.2.8 Medtronic plc
5.2.8.1 Company Overview
5.2.8.2 Role of Medtronic plc in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.8.3 Financials
5.2.8.4 Recent Developments
5.2.8.5 Analyst Perspectives
5.2.9 Nanox.AI Ltd.
5.2.9.1 Company Overview
5.2.9.2 Role of Nanox.AI Ltd. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.9.3 Key Developments
5.2.9.4 Analyst Perception
5.2.10 Paige.AI
5.2.10.1 Company Overview
5.2.10.2 Role of Paige.AI in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.10.3 Key Developments
5.2.10.4 Analyst Perspective
5.2.11 RadNet, Inc.
5.2.11.1 Company Overview
5.2.11.2 Role of RadNet, Inc. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.11.3 Financials
5.2.11.4 Analyst Perception
5.2.12 Shanghai United Imaging Healthcare Co., Ltd.
5.2.12.1 Company Overview
5.2.12.2 Role of Shanghai United Imaging Healthcare Co., Ltd. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.12.3 Product Portfolio
5.2.12.4 Analyst Perception
5.2.13 Siemens Healthineers AG
5.2.13.1 Company Overview
5.2.13.2 Role of Siemens Healthineers AG in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.13.3 Financials
5.2.13.4 Analyst Perception
5.2.14 Tempus
5.2.14.1 Company Overview
5.2.14.2 Role of Tempus in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.14.3 Key Developments
5.2.14.4 Analyst Perception
5.2.15 Viz.ai, Inc.
5.2.15.1 Company Overview
5.2.15.2 Role of Viz.ai, Inc. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.2.15.3 Key Developments
5.2.15.4 Analyst Perception
5.3 Company Snapshots
5.3.1 AI4MedImaging Medical Solutions S.A.
5.3.1.1 Company Overview
5.3.1.2 Role of AI4MedImaging Medical Solutions S.A. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.3.1.3 Key Developments
5.3.2 Ever Fortune.AI Co., Ltd.
5.3.2.1 Company Overview
5.3.2.2 Role of Ever Fortune.AI Co., Ltd. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.3.3 MedMind Technology Co., Ltd.
5.3.3.1 Company Overview
5.3.3.2 Role of MedMind Technology Co., Ltd. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.3.4 AIRS Medical Inc.
5.3.4.1 Company Overview
5.3.4.2 Role of AIRS Medical Inc. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.3.4.3 Key Developments
5.3.5 CU-BX Automotive Technologies Ltd.
5.3.5.1 Company Overview
5.3.5.2 Role of CU-BX Automotive Technologies Ltd. in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.3.6 Annalise-AI
5.3.6.1 Company Overview
5.3.6.2 Role of Annalise-AI in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.3.6.3 Key Developments
5.3.7 AZmed SAS
5.3.7.1 Company Overview
5.3.7.2 Role of AZmed SAS in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.3.7.3 Key Developments
5.3.8 Smart Soft Healthcare AD
5.3.8.1 Company Overview
5.3.8.2 Role of Smart Soft Healthcare AD in the Global Artificial Intelligence/Machine Learning Medical Device Market
5.3.8.3 Key Developments
Table 1: Global Artificial Intelligence/Machine Learning Medical Device Market, Key Developments Analysis, January 2018-February 2023
Table 2: Key Questions Answered in the Report
Table 3: Parameters for Realistic, Optimistic, and Pessimistic Growth Scenarios in Global Artificial Intelligence/Machine Learning Medical Device Market
Table 4: Funding Scenarios in Global Artificial Intelligence/Machine Learning Medical Device Market, January 2018-January 2023
Table 5: Global Artificial Intelligence/Machine Learning Medical Device Market, Applications of AI-Enabled Medical Devices in Several Clinical Areas
Table 6: Start-Ups in the Global Artificial Intelligence/Machine Learning Medical Device Market
Table 7: Global Artificial Intelligence/Machine Learning Medical Device Market, Some Players in Radiology
Table 8: Global Artificial Intelligence/Machine Learning Medical Device Market, Startups in Radiology
Table 9: Global Artificial Intelligence/Machine Learning Medical Device Market, Some Players in Cardiology
Table 10: Global Artificial Intelligence/Machine Learning Medical Device Market, Some Players in Hematology
Table 11: Global Artificial Intelligence/Machine Learning Medical Device Market, Risk Categorization of SaMD by the FDA
Table 12: North America Artificial Intelligence/Machine Learning Medical Device Market, Impact Analysis
Table 13: Europe Artificial Intelligence/Machine Learning Medical Device Market, Impact Analysis
Table 14: Asia-Pacific Artificial Intelligence/Machine Learning Medical Device Market, Impact Analysis
Table 15: Rest-of-the-World Artificial Intelligence/Machine Learning Medical Device Market, Impact Analysis
Figure 1: Global Artificial Intelligence/Machine Learning Medical Device Market, Healthcare Workflow on Introduction of AI/ML-Enabled Medical Devices
Figure 2: Global Artificial Intelligence/Machine Learning Medical Device Market, Impact Analysis
Figure 3: Global Artificial Intelligence/Machine Learning Medical Device Market (by Clinical Area), % Share, 2021 and 2032
Figure 4: Global Artificial Intelligence/Machine Learning Medical Device Market (by Region), $Million, 2022 and 2032
Figure 5: Global Artificial Intelligence/Machine Learning Medical Device Market Segmentation
Figure 6: Global Artificial Intelligence/Machine Learning Medical Device Market: Research Methodology
Figure 7: Primary Research Methodology
Figure 8: Bottom-Up Approach (Segment-Wise Analysis)
Figure 9: Top-Down Approach (Segment-Wise Analysis)
Figure 10: Global Artificial Intelligence/Machine Learning Medical Device Market Size and Growth Potential (Realistic Growth Scenario), $Million, 2021-2032
Figure 11: Global Artificial Intelligence/Machine Learning Medical Device Market Size and Growth Potential (Optimistic Growth Scenario), $Million, 2021-2032
Figure 12: Global Artificial Intelligence/Machine Learning Medical Device Market Size and Growth Potential (Pessimistic Growth Scenario), $Million, 2021-2032
Figure 13: Global Artificial Intelligence/Machine Learning Medical Device Market, Relevancy of AI in Healthcare
Figure 14: Global Artificial Intelligence/Machine Learning Medical Device Market, AI’s Role in Assisting the Various Stakeholders in Healthcare Settings
Figure 15: Global Artificial Intelligence/Machine Learning Medical Device Market, Different Types of AI/ML Algorithms in Healthcare
Figure 16: Global Artificial Intelligence/Machine Learning Medical Device Market Key Trends, Market Shift, 2022-2032
Figure 17: Global Artificial Intelligence/Machine Learning Medical Device Market, Changes in Traditional Healthcare Business Models due to Integration of AI in Medical Devices
Figure 18: Global Artificial Intelligence/Machine Learning Medical Device Market, Recommendations for Key Players
Figure 19: Global Artificial Intelligence/Machine Learning Medical Device Market, Patent Analysis (by Country), January 2018-January 2023
Figure 20: Global Artificial Intelligence/Machine Learning Medical Device Market, Patent Analysis (by Year), January 2018-January 2023
Figure 21: Global Artificial Intelligence/Machine Learning Medical Device Market Product Benchmarking
Figure 22: Artificial Intelligence/Machine Learning Medical Device Market, End User Perception
Figure 23: General Procedure of Artificial Intelligence (AI)-Based Applications to Identify COVID-19 Symptoms
Figure 24: Global Artificial Intelligence/Machine Learning Medical Device Market, Impact Analysis
Figure 25: Diverse Range of AI Applications in Medical Field
Figure 26: Regulatory Approvals for AI-Enabled Solutions, 2019-2022
Figure 27: Global Artificial Intelligence/Machine Learning Medical Device Market, Applications of Wearable Sensors in Healthcare
Figure 28: Number of CT Scanners in Australia Per One Million Inhabitants, 2014-2021
Figure 29: Global Artificial Intelligence/Machine Learning Medical Device Market (by Product Type)
Figure 30: Global Artificial Intelligence/Machine Learning Medical Device Market, Incremental Opportunity (by Product Type), $Million, 2022-2032
Figure 31: Global Artificial Intelligence/Machine Learning Medical Device Market, Growth-Share Matrix (by Product Type), 2022-2032
Figure 32: Global Artificial Intelligence/Machine Learning Medical Device Market (System/Hardware), $Million, 2021-2032
Figure 33: Global Artificial Intelligence/Machine Learning Medical Device Market (Software-as-a-Medical Device), $Million, 2021-2032
Figure 34: Global Artificial Intelligence/Machine Learning Medical Device Market (by Clinical Area)
Figure 35: Global Artificial Intelligence/Machine Learning Medical Device Market, Incremental Opportunity (by Clinical Area), $Million, 2022-2032
Figure 36: Global Artificial Intelligence/Machine Learning Medical Device Market, Growth-Share Matrix (Clinical Area), 2022-2032
Figure 37: Global Artificial Intelligence/Machine Learning Medical Device Market (Radiology), $Million, 2021-2032
Figure 38: Global Artificial Intelligence/Machine Learning Medical Device Market (Diagnostic Assistance), $Million, 2021-2032
Figure 39: Global Artificial Intelligence/Machine Learning Medical Device Market (Imaging), $Million, 2021-2032
Figure 40: Global Artificial Intelligence/Machine Learning Medical Device Market (Image Reconstruction), $Million, 2021-2032
Figure 41: Global Artificial Intelligence/Machine Learning Medical Device Market (Others), $Million, 2021-2032
Figure 42: Global Artificial Intelligence/Machine Learning Medical Device Market (Cardiology), $Million, 2021-2032
Figure 43: Global Artificial Intelligence/Machine Learning Medical Device Market (Electrocardiography-Based Arrhythmia), $Million, 2021-2032
Figure 44: Global Artificial Intelligence/Machine Learning Medical Device Market (Hemodynamics and Vital Signs Monitoring), $Million, 2021-2032
Figure 45: Global Artificial Intelligence/Machine Learning Medical Device Market (Others), $Million, 2021-2032
Figure 46: Global Artificial Intelligence/Machine Learning Medical Device Market (Hematology), $Million, 2021-2032
Figure 47: Global Artificial Intelligence/Machine Learning Medical Device Market (Others), $Million, 2021-2032
Figure 48: Global Artificial Intelligence/Machine Learning Medical Device Market Share (by Region), 2022-2032
Figure 49: Artificial Intelligence/Machine Learning Medical Device Market, Number of FDA Approved AI/ML-Enabled Medical Devices, 2015-2022
Figure 50: North America Artificial Intelligence/Machine Learning Medical Device Market, Incremental Opportunity (by Country), $Million, 2022-2032
Figure 51: North America Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 52: North America Artificial Intelligence/Machine Learning Medical Device Market (by Country), % Share, 2021 and 2032
Figure 53: U.S. Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 54: Canada Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 55: Artificial Intelligence/Machine Learning Medical Device Market, Number of CE Marked AI/ML-Enabled Medical Devices, 2015-2019
Figure 56: Global Medical Artificial Intelligence/Machine Learning Medical Device Market Guidelines for Determining the Trustworthiness of an AI-Enabled Device as per EU Standards
Figure 57: Europe Artificial Intelligence/Machine Learning Medical Device Market, Incremental Opportunity (by Country), $Million, 2022-2032
Figure 58: Europe Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 59: Europe Artificial Intelligence/Machine Learning Medical Device Market (by Country), % Share, 2021 and 2032
Figure 60: Germany Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 61: France Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 62: Italy Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 63: U.K. Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 64: Spain Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 65: Rest-of-Europe Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 66: Asia-Pacific Artificial Intelligence/Machine Learning Medical Device Market, Incremental Opportunity (by Country), $Million, 2022-2032
Figure 67: Asia-Pacific Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 68: Asia-Pacific Artificial Intelligence/Machine Learning Medical Device Market (by Country), % Share, 2021 and 2032
Figure 69: Artificial Intelligence/Machine Learning Medical Device Market, Number of AI/ML-Enabled SaMDs in Japan, 2018-2020
Figure 70: Japan Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 71: China Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 72: Australia Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 73: South Korea Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 74: Artificial Intelligence/Machine Learning Medical Device Market, AI Talent Concentration Comparison of Key Countries, 2021
Figure 75: India Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 76: Rest-of-Asia-Pacific Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 77: Rest-of-the-World Artificial Intelligence/Machine Learning Medical Device Market, Incremental Opportunity (by Country), $Million, 2022-2032
Figure 78: Rest-of-the-World Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 79: Rest-of-the-World Artificial Intelligence/Machine Learning Medical Device Market (by Country), % Share, 2021 and 2032
Figure 80: Brazil Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 81: Mexico Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 82: Israel Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 83: Rest-of-Rest-of-the-World Artificial Intelligence/Machine Learning Medical Device Market, $Million, 2021-2032
Figure 84: Global Artificial Intelligence/Machine Learning Medical Device Number of Key Developments and Strategies, January 2018-January 2023
Figure 85: Regulatory and Legal Activities, January 2018-January 2023
Figure 86: Funding Activities, January 2018-January 2023
Figure 87: New Offerings, January 2018-January 2023
Figure 88: Mergers and Acquisitions, January 2018-January 2023
Figure 89: Partnerships, Alliances, and Business Expansions, January 2018-January 2023
Figure 90: Aidoc Medical, Ltd.: Overall Product Portfolio
Figure 91: Canon Inc.: Overall Product Portfolio
Figure 92: Canon Inc.: Overall Financials, $Million, 2019-2021
Figure 93: Canon Inc.: Net Revenue (by Segment), $Million, 2019-2021
Figure 94: Canon Inc.: Net Revenue (by Region), $Million, 2019-2021
Figure 95: Canon Inc.: R&D Expenditure, $Million, 2019-2021
Figure 96: CellaVision AB: Overall Product Portfolio
Figure 97: CellaVision AB: Overall Financials, $Million, 2019-2021
Figure 98: CellaVision AB: Net Revenue (by Region), $Million, 2019-2021
Figure 99: CellaVision AB: R&D Expenditure, $Million, 2019-2021
Figure 100: Clarius Mobile Health Corp.: Overall Product Portfolio
Figure 101: General Electric Company: Overall Product Portfolio
Figure 102: General Electric Company: Overall Financials, $Million, 2019-2021
Figure 103: General Electric Company: Net Revenue (by Segment), $Million, 2019-2021
Figure 104: General Electric Company: Net Revenue (by Region), $Million, 2019-2021
Figure 105: General Electric Company: R&D Expenditure, $Million, 2019-2021
Figure 106: Hyperfine Inc.: Overall Product Portfolio
Figure 107: Hyperfine Inc.: Overall Financials, $Million, 2020-2021
Figure 108: Hyperfine Inc.: Net Revenue (by Segment), $Million, 2020-2021
Figure 109: Hyperfine Inc.: R&D Expenditure, $Million, 2020-2021
Figure 110: Koninklijke Philips N.V.: Overall Product Portfolio
Figure 111: Koninklijke Philips N.V.: Overall Financials, $Million, 2019-2021
Figure 112: Koninklijke Philips N.V.: Net Revenue (by Segment), $Million, 2019-2021
Figure 113: Koninklijke Philips N.V.: Revenue (by Region), $Million, 2019-2021
Figure 114: Koninklijke Philips N.V.: R&D Expenditure, $Million, 2019-2021
Figure 115: Medtronic plc: Overall Product Portfolio
Figure 116: Medtronic plc: Overall Financials, $Million, 2020-2022
Figure 117: Medtronic plc: Net Revenue (by Segment), $Million, 2020-2022
Figure 118: Medtronic plc: Net Revenue (by Region), $Million, 2020-2022
Figure 119: Medtronic plc: R&D Expenditure, $Million, 2020-2022
Figure 120: Nanox.AI Ltd.: Overall Product Portfolio
Figure 121: Paige.AI: Overall Product Portfolio
Figure 122: RadNet, Inc.: Overall Product Portfolio
Figure 123: RadNet, Inc.: Overall Financials, $Million, 2019-2021
Figure 124: Shanghai United Imaging Healthcare Co., Ltd.: Overall Product Portfolio
Figure 125: Siemens Healthineers AG: Overall Product Portfolio
Figure 126: Siemens Healthineers AG: Overall Financials, $Million, 2020-2022
Figure 127: Siemens Healthineers AG: Net Revenue (by Segment), $Million, 2020-2022
Figure 128: Siemens Healthineers AG: Net Revenue (by Region), $Million, 2020-2022
Figure 129: Siemens Healthineers AG: R&D Expenditure, $Million, 2020-2022
Figure 130: Tempus: Overall Product Portfolio
Figure 131: Viz.ai, Inc.: Overall Product Portfolio
Figure 132: AI4MedImaging Medical Solutions S.A.: Overall Product Portfolio
Figure 133: Ever Fortune.AI Co., Ltd.: Overall Product Portfolio
Figure 134: MedMind Technology Co., Ltd.: Overall Product Portfolio
Figure 135: AIRS Medical Inc.: Overall Product Portfolio
Figure 136: CU-BX Automotive Technologies Ltd.: Overall Product Portfolio
Figure 137: Annalise-AI: Overall Product Portfolio
Figure 138: AZmed SAS: Overall Product Portfolio
Figure 139: Smart Soft Healthcare AD: Overall Product Portfolio
Market Report Coverage
Artificial Intelligence/Machine Learning Medical Device Market |
|||
Base Year |
2021 |
Market Size in 2022 |
$4,011.7 Million |
Forecast Period |
2022-2032 |
Value Projection and Estimation by 2032 |
$35,458.2 Million |
CAGR During Forecast Period |
24.35% |
Number of Tables |
15 |
Number of Pages |
208 |
Number of Figures |
139 |
Key Market Players and Competition Synopsis
The global artificial intelligence/machine learning medical device market is highly fragmented, with over 250 players, including established companies and startups.
Key Companies Profiled
• 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
• RadNet, Inc.
• Shanghai United Imaging Healthcare Co., Ltd.
• Siemens Healthineers AG
• Tempus
• Viz.ai, Inc.
How can this report add value to an organization?
Type: The clinical area segment helps the reader understand the different applications for which AI-enabled medical devices have been approved in the market. Moreover, the study provides the reader with a detailed understanding of the different types of systems and software-as-a-medical devices approved as AI-enabled medical devices globally.
Growth/Marketing Strategy: The global artificial intelligence/machine learning medical device market has seen major development by key players operating in the market, such as business expansion, partnership, collaboration, and joint ventures. Partnerships, alliances, business expansions, and regulatory activities accounted for the maximum number of key developments, i.e., nearly 65.00% of the total developments in the global artificial intelligence/machine learning medical device market.
Competitive Strategy: The global artificial intelligence/machine learning medical device market is highly fragmented, with over 250 players, including established companies and startups. Key players in the global artificial intelligence/machine learning medical device market analyzed and profiled in the study involve established and emerging players that offer different AI-enabled medical devices. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.
Artificial Intelligence/Machine Learning Medical Device Industry and Technology Overview
The global artificial intelligence/machine learning medical device market was valued at $4,011.7 million in 2022 and is anticipated to reach $35,458.2 million by 2032, witnessing a CAGR of 24.35% during the forecast period 2022-2032. The market is driven by factors such as the presence of a large ecosystem of companies offering AI solutions, growing demand in the field of radiology and cardiology, growing demand for wearable sensors, and large number of government initiatives.
Market Lifecycle Stage
The global artificial intelligence/machine learning medical device market is highly fragmented, and the number of FDA and CE marked approvals of AI-enabled medical devices is increasing each year. This market still holds significant potential for growth as technological developments and investments into AI in healthcare are ongoing globally.
The opportunity for growth of the global artificial intelligence/machine learning medical device market lies in innovations in technology and the further development of AI-based medical devices enabling diagnostic accuracy and productivity.
Figure: Global Artificial Intelligence/Machine Learning Medical Device Market, Market Size and Forecast, 2021, 2022, and 2032
Impact of COVID-19
Immediately after the outbreak of COVID-19, the focus of the healthcare systems switched to managing the pandemic and related crises. This led to hospital budgets shrinking and thus resulted in the grim growth of AI. However, AI is being deployed in radiology departments across the globe to help fight COVID-19, and AI-based tools played an important role in fighting the COVID-19 pandemic. The adoption of AI in clinical settings increased during the pandemic owing to the numerous advantages of AI in tackling COVID-19.
Following the COVID-19 pandemic, the market is projected to exhibit rapid growth, primarily due to the increased adoption of AI-based solutions resulting from the pandemic. The market growth will also be driven by the surge in research activities surrounding AI-enabled solutions, advancements in deep learning and machine learning algorithms, introduction of new products to the market, emergence of local businesses, and growing adoption of AI-based solutions for various therapeutic applications.
Market Segmentation:
Segmentation 1: by Product Type
• System/Hardware
• Software-as-a-Medical Device
The global artificial intelligence/machine learning medical device market (by product type) is expected to be dominated by the software-as-a-medical device segment.
Segmentation 2: by Clinical Area
• Radiology
• Cardiology
• Hematology
• Others
The global artificial intelligence/machine learning medical device market (by clinical area) is expected to be dominated by the radiology segment.
Segmentation 3: Radiology (by Type)
• Diagnostic Assistance
• Imaging
• Image Reconstruction
• Others
The global radiology artificial intelligence/machine learning medical device market (by type) is expected to be dominated by the diagnostic assistance segment.
Segmentation 4: Cardiology (by Type)
• Electrocardiography-Based Arrhythmia Detection
• Hemodynamics and Vital Signs Monitoring
• Others
The global cardiology artificial intelligence/machine learning medical device market (by type) is expected to be dominated by the electrocardiography-based arrhythmia detection segment.
Segmentation 5: by Region
• North America - U.S., Canada
• Europe - Germany, U.K., France, Italy, Spain, and Rest-of-Europe
• Asia-Pacific - China, Japan, India, Australia, South Korea, and Rest-of-Asia-Pacific
• Rest-of-the-World - Brazil, Mexico, Israel, and Rest-of-Rest-of-the-World
The global artificial intelligence/machine learning medical device market (by region) is dominated by the North America region.
Recent Developments in Global Artificial Intelligence/Machine Learning Medical Device Market
• In October 2022, Koninklijke Philips N.V. received the U.S. FDA 510(k) approval for its AI-enabled MRCAT head and neck radiotherapy application.
• In June 2022, Aidoc Medical, Ltd. raised a $110 million Series D round investment to address the challenges faced by health systems by using AI.
• In June 2022, Hyperfine Inc. received FDA 510(k) clearance for the MRI device Swoop. The Swoop system software uses deep learning to deliver clear images that aid in clinical diagnosis.
• In April 2022, Clarius Mobile Health Corp.’s range of ultra-portable scanners, Clarius HD, was approved by Health Canada.
• In March 2022, Clarius Mobile Health Corp. raised $20.0 million in funding to expand its commercial-scale activities.
• In December 2021, Hyperfine Inc. partnered with Brain Tumor Foundation to utilize Hyperfine's Swoop devices to provide neuroimaging worldwide.
• In December 2021, Hyperfine Inc. announced the Health Canada licensing of Swoop as well as the launch of the imaging system in Canada.
• In September 2021, Aidoc Medical, Ltd. and Subtle Medical partnered to bring end-to-end AI solutions to medical imaging.
Demand - Drivers and Limitations
The following are the drivers for the global artificial intelligence/machine learning medical device market:
• Presence of a Large Ecosystem of Companies Offering AI Solutions Targeting the Diverse Range of Applications of AI in the Healthcare
• Growing Demand in the Field of Radiology and Cardiology Increasing Adoption of AI-Enabled Solutions due to Their Ability to Shorten Waiting Times and Reduce Burden on Healthcare System
• Growing Demand for Wearable Sensors to Increase Adoption of AI-Enabled Medical Devices for Home-Based Care
• Large Number of Government Initiatives Advancing the Research and Development of AI-Enabled Medical Devices
The market is expected to face some limitations as well due to the following challenges:
• Lack of Transparency and Concerns around Data Sharing Leading to Cybersecurity Concerns and Hindering Adoption of AI in Healthcare
• Challenges Related to Identification and Minimization of Bias in AI Algorithms Leading to Concerns Surrounding the Reliability of Diagnosis and Thus Hindering the Use of AI-Enabled Solutions
Analyst’s Thoughts
To emphasize the potential of the global artificial intelligence/machine learning medical device market, Swati Sood, Principal Analyst - BIS Research, states, “AI in healthcare is an emerging topic and has immense potential to reduce wait times and decrease the increasing burden on the global healthcare system. This market is expected to register significant growth during the forecast period 2022-2032.”
Artificial Intelligence/Machine Learning Medical Device Market - A Global and Regional Analysis
Focus on Product Type, Clinical Area, and Country Analysis - Analysis and Forecast, 2022-2032
Frequently Asked Questions
According to BIS Research, ML-enabled medical devices are smart medical devices that can learn from their datasets and thus help in the diagnosis, treatment, or monitoring of diseases. They can transform the field of healthcare by uncovering new insights and performing predictive analysis, among others.
Some of the key trends witnessed in the global artificial intelligence/machine learning medical device market include updations of government regulations to accommodate SaMDs, rigorous PMA approval applicable to only a few medical devices, and most AI-enabled medical devices being used as clinical decision support tools rather than being used for independent diagnosis.
The global artificial intelligence/machine learning medical device market has seen major development by key players operating in the market, such as business expansions, partnerships, collaborations, regulatory and legal activities, funding activities, product launches, and acquisitions and mergers. According to BIS Research analysis, most of the companies preferred partnerships, alliances, business expansions, and regulatory and legal activities as a strategy to further increase their growth in the global artificial intelligence/machine learning medical device market.
• Funding scenario
• Business models
• Regulatory approval scenario
• End user perception
• Recommendations for players entering the market
• Impact of COVID-19
• Region-level market segmentation by clinical area (and further segmentation by type)
• Region-level market segmentation by product type
• “Digital transformation: Adoption of AI in healthcare” provided for each region
Digital healthcare companies that are developing, manufacturing, and commercializing AI-enabled medical devices, should buy this report.