市場調査レポート
商品コード
1255206

人工知能/機械学習医療機器市場 - 世界および地域別分析:製品タイプ別、臨床分野別、国別 - 分析と予測(2022年~2032年)

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

出版日: | 発行: BIS Research | ページ情報: 英文 213 Pages | 納期: 1~5営業日

● お客様のご希望に応じて、既存データの加工や未掲載情報(例:国別セグメント)の追加などの対応が可能です。  詳細はお問い合わせください。

価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=149.62円
人工知能/機械学習医療機器市場 - 世界および地域別分析:製品タイプ別、臨床分野別、国別 - 分析と予測(2022年~2032年)
出版日: 2023年04月04日
発行: BIS Research
ページ情報: 英文 213 Pages
納期: 1~5営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界の人工知能/機械学習医療機器の市場規模は、2022年に40億1,170万米ドルなりました。

同市場は今後、2022年~2032年にかけて24.35%のCAGRで拡大し、2032年には354億5,820万米ドルに達すると予測されています。

当レポートでは、世界の人工知能/機械学習医療機器市場について調査し、市場の概要とともに、製品タイプ別、臨床分野別、地域別の動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 市場

  • 世界市場の見通し
  • 業界の見通し
  • 世界の人工知能/機械学習医療機器に対するCOVID-19の影響
  • ビジネスダイナミクス

第2章 世界の人工知能/機械学習医療機器市場(製品タイプ別)

  • 機会評価
  • 成長シェアマトリックス
  • システム/ハードウェア
  • 医療機器としてのソフトウェア

第3章 世界の人工知能/機械学習医療機器市場(臨床分野別)

  • 機会評価
  • 成長シェアマトリックス
  • 放射線科
  • 心臓病科
  • 血液科
  • その他

第4章 世界の人工知能/機械学習医療機器市場(地域別)

  • 北米の人工知能/機械学習医療機器市場
  • 欧州の人工知能・機械学習医療機器市場
  • アジア太平洋の人工知能/機械学習医療機器市場
  • その他の地域の人工知能/機械学習医療機器市場

第5章 市場-競合ベンチマーキングと企業プロファイル

  • 競合ベンチマーキング
  • 企業プロファイル
    • 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.
  • 会社のスナップショット
    • AI4MedImaging Medical Solutions S.A.
    • Ever Fortune.AI Co., Ltd.
    • MedMind Technology Co., Ltd.
    • AIRS Medical Inc.
    • CU-BX Automotive Technologies Ltd.
    • Annalise-AI
    • AZmed SAS
    • Smart Soft Healthcare AD
図表

List of Figures

  • 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

List of Tables

  • 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
目次
Product Code: BHD1349SA

“Global Artificial Intelligence/Machine Learning Medical Device Market to Reach $35,458.2 Million by 2032.”

Industry 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.

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

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.

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.

Table of Contents

1 Markets

  • 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 Global Artificial Intelligence/Machine Learning Medical Device Market (by Product Type)

  • 2.1 Opportunity Assessment
  • 2.2 Growth-Share Matrix
  • 2.3 System/Hardware
  • 2.4 Software-as-a-Medical Device

3 Global Artificial Intelligence/Machine Learning Medical Device Market (by Clinical Area)

  • 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 Global Artificial Intelligence/Machine Learning Medical Device Market (by Region)

  • 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 Markets - Competitive Benchmarking & Company Profiles

  • 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