Market Size and Growth
As per the US AI-Enabled Medical Devices Market size analysis conducted by the BRI team, the US AI-enabled medical devices market is expected to record a CAGR of 39.37% from 2025 to 2034. In 2025, the market size was USD 19.89 Billion. By 2034, the valuation is anticipated to reach USD 392.24 Billion.
Overview
As per the industry experts at BRI, the U.S. AI-enabled medical devices market is likely to witness an astounding CAGR during the forecast period. This could be attributed to visible advancements in ML/AI algorithms, a rise in investment in digital health, and a call for personalized treatments and more precise diagnostics. The ongoing trends include the integration of AI into robot-assisted surgery, the dominance of AI inrobot-assisted surgery, and the growing vitality of the software solutions and ML technology. The major challenges encompass complex regulatory approvals.
Key Trends & Drivers
- Technological Innovation to Determine Growth: Continual enhancements in ML and AI algorithms, particularly deep learning, are improving medical devices’ capabilities. Ability of AI to analyze complex medical data like MRIs and X-Rays result in more precise and earlier diagnoses. AI-enabled devices to support the personalized treatment strategies by analyzing the patients’ lifestyles and genetics for delivering tailored therapies.
- Rise in Frequency of Robot-assisted Surgery to Catalyze the Market: AI-powered medical imaging technologies, especially the ones used in radiology, do represent a major portion of authorized AI-enabled devices. AI’s integration with robotics does improve surgical accuracy, resulting in minimally invasive procedures. Growing adoption of telehealth solutions for remote patient monitoring does contribute to expansion of the market.
Report Scope
| Feature of the Report | Details |
| Market Size in 2025 | USD 19.89 Billion |
| Projected Market Size in 2034 | USD 392.24 Billion |
| Market Size in 2024 | USD 14.27 Billion |
| CAGR Growth Rate | 39.37% CAGR |
| Base Year | 2024 |
| Forecast Period | 2025-2034 |
| Key Segment | By Component, Technology, Therapeutic Area, End-use and Region |
| Report Coverage | Revenue Estimation and Forecast, Company Profile, Competitive Landscape, Growth Factors and Recent Trends |
| Buying Options | Request tailored purchasing options to fulfil your requirements for research. |
SWOT Analysis
- Strengths: AI algorithms are capable of analyzing medical images (CT scans, MRIs, X-Rays) more precisely and faster than the conventional methods, thereby reducing the rates of misdiagnoses. AI is integral to the services that provide better patient experience, offer real-time monitoring, and foster personalized therapies. Smooth software-hardware ecosystems do convert the raw device into clinical insights that are actionable.
- Weaknesses: The higher cost of AI-enabled medical devices could act as a barrier to access, especially for small entrants. Navigation of the evolving regulatory landscape and ascertainment of product approval could be challenging, which would need proper consideration of patient safety and data privacy.
- Opportunities: AI facilitates tailored healthcare on the basis of individual genetic data, clinical records, and lifestyle, thereby resulting in more effective treatments. Integrating AI into wearables and the home-monitoring devices enables continuous patient oversight, especially for chronic conditions. AI does support the ongoing trend of more decentralized care, which makes healthcare more accessible.
- Threats: Protection of sensitive patient data and ascertaining strong cybersecurity measures are critical toward maintenance of compliance and trust. Keeping the regulatory framework adaptive and dynamic for keeping pace with the advancing AI technology remains a notable challenge. Questions regarding AI-driven decisions’ ethical implications along with the role of human clinical judgment need proper consideration.
List of the prominent players in the US AI-Enabled Medical Devices Market:
- Siemens Healthineers
- GE HealthCare
- Philips Healthcare
- Medtronic
- Johnson & Johnson (Ethicon)
- Stryker
- Canon Medical Systems
- Zimmer Biomet
- Abbott Laboratories
- Boston Scientific
- Exo Imaging Inc.
- Empatica
- Aidoc
- Clew Medical
- Eko Healthcare
- Paige AI Inc.
- Others
The US AI-Enabled Medical Devices Market is segmented as follows:
By Component
- Software
- Hardware
- AI-enabled Medical Devices
- Smart Wearables
- Services
By Technology
- Machine Learning
- Deep Learning
- Supervised
- Unsupervised
- Natural Language Processing (NLP)
- Computer Vision
- Context-Aware Computing
By Therapeutic Area
- Cardiology
- Neurology
- Radiology
- Oncology
- Mental and Behavioral Health
- Ophthalmology
By End-use
- Hospitals & Clinics
- Diagnostic Centers
- Ambulatory Surgical Centers (ASCs)
- Home Care Settings
[embedsocial_reviews id=”d4ae80cffae3d938f997111953699a733c8e6f99″]