Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device Market 2026 by Company, Regions, Type and Application, Forecast to 2032
Description
According to our (Global Info Research) latest study, the global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market size was valued at US$ 14993 million in 2025 and is forecast to a readjusted size of US$ 49715 million by 2032 with a CAGR of 18.4% during review period.
Artificial Intelligence or Machine Learning (AI/ML) Medical Devices refer to regulated medical hardware systems that integrate AI/ML algorithms to support clinical decision-making, automate measurement, or guide therapy. Unlike pure software tools, these products are typically delivered as an integrated device (e.g., imaging equipment with embedded AI, bedside monitoring devices, AI-enabled wearables, or robotic/therapeutic systems) and must meet medical device compliance requirements. Core value is generated through improved diagnostic accuracy, faster workflow, earlier detection, and more standardized clinical outcomes, especially in high-volume settings such as radiology, ophthalmology, cardiology, and ICU monitoring.
Gross margin profiles are generally attractive compared with traditional hardware-only medical devices, because AI features enable premium pricing and recurring revenue. Hardware-heavy products (e.g., imaging systems, robots) typically show mid-level gross margins driven by BOM cost and manufacturing complexity, while AI-enabled monitoring devices and wearables can reach higher margins through scale manufacturing and subscription add-ons. The highest margins are often achieved when vendors monetize software updates, per-use analytics, or multi-year service contracts, although margins may be diluted by clinical validation costs, post-market surveillance, and regulatory maintenance for model updates.
Key market dynamics include rapid adoption in workflow-intensive departments, rising demand for early screening and chronic disease management, and policy-driven incentives for efficiency and quality control. Competitive differentiation increasingly depends on real-world clinical evidence, data access, interpretability, cybersecurity, and the ability to manage “locked” vs. adaptive learning under regulatory frameworks. Over the next few years, the market will likely shift from single-task AI modules toward multi-modal, multi-disease platforms, while partnerships between device OEMs, hospitals, and AI developers accelerate commercialization and global deployment.
This report is a detailed and comprehensive analysis for global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market. Both quantitative and qualitative analyses are presented by company, by region & country, by Type and by Application. As the market is constantly changing, this report explores the competition, supply and demand trends, as well as key factors that contribute to its changing demands across many markets. Company profiles and product examples of selected competitors, along with market share estimates of some of the selected leaders for the year 2025, are provided.
Key Features:
Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market size and forecasts, in consumption value ($ Million), 2021-2032
Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market size and forecasts by region and country, in consumption value ($ Million), 2021-2032
Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market size and forecasts, by Type and by Application, in consumption value ($ Million), 2021-2032
Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market shares of main players, in revenue ($ Million), 2021-2026
The Primary Objectives in This Report Are:
To determine the size of the total market opportunity of global and key countries
To assess the growth potential for Artificial Intelligence or Machine Learning (AI/ML) Medical Device
To forecast future growth in each product and end-use market
To assess competitive factors affecting the marketplace
This report profiles key players in the global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market based on the following parameters - company overview, revenue, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include GE HealthCare Technologies, Siemens Healthineers, Philips Healthcare (AI-enabled solutions), Canon Medical Systems (Altivity AI), Aidoc, Viz.ai, Lunit, Cleerly, PathAI, Tempus (AI Oncology), etc.
This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
Market segmentation
Artificial Intelligence or Machine Learning (AI/ML) Medical Device market is split by Type and by Application. For the period 2021-2032, the growth among segments provides accurate calculations and forecasts for Consumption Value by Type and by Application. This analysis can help you expand your business by targeting qualified niche markets.
Market segment by Type
System Or Hardware
Software-as-a Medical Devices
Market segment by Deployment Architecture
Edge/On-device AI
On-premise Server
Cloud AI
Others
Market segment by Clinical Use Type
Radiology AI
Ophthalmology AI
Digital Pathology AI
Cardiology AI
Others
Market segment by Application
Medical Imaging Analysis
Disease Prediction and Diagnosis
Patient Monitoring and Care
Medical Device Performance Optimization
Therapeutic Progress Tracking
Market segment by players, this report covers
GE HealthCare Technologies
Siemens Healthineers
Philips Healthcare (AI-enabled solutions)
Canon Medical Systems (Altivity AI)
Aidoc
Viz.ai
Lunit
Cleerly
PathAI
Tempus (AI Oncology)
Quibim
Digital Diagnostics (LumineticsCore)
Eyenuk (EyeArt)
Optomed / AEYE Health
VUNO
Infervision
Rad AI
AliveCor
Airdoc Technology
Digital Diagnostics
Eyenuk
Market segment by regions, regional analysis covers
North America (United States, Canada and Mexico)
Europe (Germany, France, UK, Russia, Italy and Rest of Europe)
Asia-Pacific (China, Japan, South Korea, India, Southeast Asia and Rest of Asia-Pacific)
South America (Brazil, Rest of South America)
Middle East & Africa (Turkey, Saudi Arabia, UAE, Rest of Middle East & Africa)
The content of the study subjects, includes a total of 13 chapters:
Chapter 1, to describe Artificial Intelligence or Machine Learning (AI/ML) Medical Device product scope, market overview, market estimation caveats and base year.
Chapter 2, to profile the top players of Artificial Intelligence or Machine Learning (AI/ML) Medical Device, with revenue, gross margin, and global market share of Artificial Intelligence or Machine Learning (AI/ML) Medical Device from 2021 to 2026.
Chapter 3, the Artificial Intelligence or Machine Learning (AI/ML) Medical Device competitive situation, revenue, and global market share of top players are analyzed emphatically by landscape contrast.
Chapter 4 and 5, to segment the market size by Type and by Application, with consumption value and growth rate by Type, by Application, from 2021 to 2032.
Chapter 6, 7, 8, 9, and 10, to break the market size data at the country level, with revenue and market share for key countries in the world, from 2021 to 2026.and Artificial Intelligence or Machine Learning (AI/ML) Medical Device market forecast, by regions, by Type and by Application, with consumption value, from 2027 to 2032.
Chapter 11, market dynamics, drivers, restraints, trends, Porters Five Forces analysis.
Chapter 12, the key raw materials and key suppliers, and industry chain of Artificial Intelligence or Machine Learning (AI/ML) Medical Device.
Chapter 13, to describe Artificial Intelligence or Machine Learning (AI/ML) Medical Device research findings and conclusion.
Artificial Intelligence or Machine Learning (AI/ML) Medical Devices refer to regulated medical hardware systems that integrate AI/ML algorithms to support clinical decision-making, automate measurement, or guide therapy. Unlike pure software tools, these products are typically delivered as an integrated device (e.g., imaging equipment with embedded AI, bedside monitoring devices, AI-enabled wearables, or robotic/therapeutic systems) and must meet medical device compliance requirements. Core value is generated through improved diagnostic accuracy, faster workflow, earlier detection, and more standardized clinical outcomes, especially in high-volume settings such as radiology, ophthalmology, cardiology, and ICU monitoring.
Gross margin profiles are generally attractive compared with traditional hardware-only medical devices, because AI features enable premium pricing and recurring revenue. Hardware-heavy products (e.g., imaging systems, robots) typically show mid-level gross margins driven by BOM cost and manufacturing complexity, while AI-enabled monitoring devices and wearables can reach higher margins through scale manufacturing and subscription add-ons. The highest margins are often achieved when vendors monetize software updates, per-use analytics, or multi-year service contracts, although margins may be diluted by clinical validation costs, post-market surveillance, and regulatory maintenance for model updates.
Key market dynamics include rapid adoption in workflow-intensive departments, rising demand for early screening and chronic disease management, and policy-driven incentives for efficiency and quality control. Competitive differentiation increasingly depends on real-world clinical evidence, data access, interpretability, cybersecurity, and the ability to manage “locked” vs. adaptive learning under regulatory frameworks. Over the next few years, the market will likely shift from single-task AI modules toward multi-modal, multi-disease platforms, while partnerships between device OEMs, hospitals, and AI developers accelerate commercialization and global deployment.
This report is a detailed and comprehensive analysis for global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market. Both quantitative and qualitative analyses are presented by company, by region & country, by Type and by Application. As the market is constantly changing, this report explores the competition, supply and demand trends, as well as key factors that contribute to its changing demands across many markets. Company profiles and product examples of selected competitors, along with market share estimates of some of the selected leaders for the year 2025, are provided.
Key Features:
Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market size and forecasts, in consumption value ($ Million), 2021-2032
Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market size and forecasts by region and country, in consumption value ($ Million), 2021-2032
Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market size and forecasts, by Type and by Application, in consumption value ($ Million), 2021-2032
Global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market shares of main players, in revenue ($ Million), 2021-2026
The Primary Objectives in This Report Are:
To determine the size of the total market opportunity of global and key countries
To assess the growth potential for Artificial Intelligence or Machine Learning (AI/ML) Medical Device
To forecast future growth in each product and end-use market
To assess competitive factors affecting the marketplace
This report profiles key players in the global Artificial Intelligence or Machine Learning (AI/ML) Medical Device market based on the following parameters - company overview, revenue, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include GE HealthCare Technologies, Siemens Healthineers, Philips Healthcare (AI-enabled solutions), Canon Medical Systems (Altivity AI), Aidoc, Viz.ai, Lunit, Cleerly, PathAI, Tempus (AI Oncology), etc.
This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
Market segmentation
Artificial Intelligence or Machine Learning (AI/ML) Medical Device market is split by Type and by Application. For the period 2021-2032, the growth among segments provides accurate calculations and forecasts for Consumption Value by Type and by Application. This analysis can help you expand your business by targeting qualified niche markets.
Market segment by Type
System Or Hardware
Software-as-a Medical Devices
Market segment by Deployment Architecture
Edge/On-device AI
On-premise Server
Cloud AI
Others
Market segment by Clinical Use Type
Radiology AI
Ophthalmology AI
Digital Pathology AI
Cardiology AI
Others
Market segment by Application
Medical Imaging Analysis
Disease Prediction and Diagnosis
Patient Monitoring and Care
Medical Device Performance Optimization
Therapeutic Progress Tracking
Market segment by players, this report covers
GE HealthCare Technologies
Siemens Healthineers
Philips Healthcare (AI-enabled solutions)
Canon Medical Systems (Altivity AI)
Aidoc
Viz.ai
Lunit
Cleerly
PathAI
Tempus (AI Oncology)
Quibim
Digital Diagnostics (LumineticsCore)
Eyenuk (EyeArt)
Optomed / AEYE Health
VUNO
Infervision
Rad AI
AliveCor
Airdoc Technology
Digital Diagnostics
Eyenuk
Market segment by regions, regional analysis covers
North America (United States, Canada and Mexico)
Europe (Germany, France, UK, Russia, Italy and Rest of Europe)
Asia-Pacific (China, Japan, South Korea, India, Southeast Asia and Rest of Asia-Pacific)
South America (Brazil, Rest of South America)
Middle East & Africa (Turkey, Saudi Arabia, UAE, Rest of Middle East & Africa)
The content of the study subjects, includes a total of 13 chapters:
Chapter 1, to describe Artificial Intelligence or Machine Learning (AI/ML) Medical Device product scope, market overview, market estimation caveats and base year.
Chapter 2, to profile the top players of Artificial Intelligence or Machine Learning (AI/ML) Medical Device, with revenue, gross margin, and global market share of Artificial Intelligence or Machine Learning (AI/ML) Medical Device from 2021 to 2026.
Chapter 3, the Artificial Intelligence or Machine Learning (AI/ML) Medical Device competitive situation, revenue, and global market share of top players are analyzed emphatically by landscape contrast.
Chapter 4 and 5, to segment the market size by Type and by Application, with consumption value and growth rate by Type, by Application, from 2021 to 2032.
Chapter 6, 7, 8, 9, and 10, to break the market size data at the country level, with revenue and market share for key countries in the world, from 2021 to 2026.and Artificial Intelligence or Machine Learning (AI/ML) Medical Device market forecast, by regions, by Type and by Application, with consumption value, from 2027 to 2032.
Chapter 11, market dynamics, drivers, restraints, trends, Porters Five Forces analysis.
Chapter 12, the key raw materials and key suppliers, and industry chain of Artificial Intelligence or Machine Learning (AI/ML) Medical Device.
Chapter 13, to describe Artificial Intelligence or Machine Learning (AI/ML) Medical Device research findings and conclusion.
Table of Contents
150 Pages
- 1 Market Overview
- 2 Company Profiles
- 3 Market Competition, by Players
- 4 Market Size Segment by Type
- 5 Market Size Segment by Application
- 6 North America
- 7 Europe
- 8 Asia-Pacific
- 9 South America
- 10 Middle East & Africa
- 11 Market Dynamics
- 12 Industry Chain Analysis
- 13 Research Findings and Conclusion
- 14 Appendix
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