Global Artificial Intelligence/Machine Learning Medical Device Market to 2032: Presence of a Large Ecosystem of Companies Offering AI Solutions Drives Growth

DUBLIN, April 27, 2023 /PRNewswire/ -- The "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" report has been added to ResearchAndMarkets.com's offering.

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.

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.

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

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.

Key Attributes:

Key Topics Covered:

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
1.2.7 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
1.4 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)

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

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