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Artificial Intelligence (AI) in Medical Devices Market Set for Record Growth - Key Insights 2025
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Regulatory Approved
A 2024 ScienceDirect study highlights that healthcare increasingly uses generative and non-generative AI tools, with medical device makers adopting AI and ML to innovate. Proper regulation ensures safe integration and builds public trust.
In March 2024, Clarius Mobile Health gained Health Canada approval for Clarius Bladder AI, a non-invasive tool that measures bladder volume in seconds. It joins the Clarius PAL HD3, PA HD3, and C3 HD3 wireless handheld ultrasound scanners in Canada.
List of Top Key Players:
Key players are driving the AI in medical devices market through collaborations, product launches, and approvals. In March 2023, NVIDIA partnered with Medtronic to integrate AI into the GI Genius endoscopy module. In November 2024, GE HealthCare launched an AI Innovation Lab to accelerate early-stage AI solutions, improve decision-making, and enhance healthcare outcomes.
GE HealthCare., Medtronic, Siemens Healthineers AG, NVIDIA Corporation, Koninklijke Philips N.V., Canon Medical Systems, USA, Inc., Aidoc, IBM, Apple Inc., Google DeepMind, HYPERFINE, INC., and Clarius among others.
Forecast Growth Projection:
Global Artificial Intelligence in Medical Devices Market Positioned for Strong Growth 2025-2032, Building on the steady momentum of 2024, the market is poised for remarkable expansion as leading players embrace innovative technologies and strategic advancements. This evolving landscape is unlocking lucrative opportunities for businesses to invest, scale, and stay ahead in an increasingly competitive and fast-moving market.
Key Industry Developments:
May 2024: MHRA launched AI Airlock, a regulatory sandbox for safe testing and deployment of AI medical devices.
March 2024: Clarius Mobile Health got Health Canada approval for Clarius PAL HD3, a wireless handheld ultrasound scanner offering high-definition imaging of superficial and deep structures via iOS and Android apps.
Market Research Process:
The Artificial Intelligence in Medical Devices Market research report by DataM Intelligence combines extensive Primary and Secondary research to provide powerful, in-depth insights. It examines key market drivers such as regulatory frameworks, evolving market conditions, competitive dynamics, historical trends, and breakthrough technologies, while spotlighting emerging innovations and potential challenges. This all-inclusive analysis uncovers high-growth opportunities and highlights possible barriers, equipping businesses to tackle market volatility and capture new avenues for success.
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Market Segments:
Product Type
July 2024: Hyperfine cleared its 9th-gen AI software, cutting MRI scan times without losing image quality, reinforcing its AI healthcare leadership.
May 2023: Formus Labs received FDA 510(k) clearance for Formus Hip, the first automated radiology software for hip replacement planning, boosting its U.S. expansion.
By Product Type: Hardware, Software, Services
By Technology: Machine Learning, Deep Learning, Natural Language Processing (NLP), Computer Vision, Others
By Application: Radiology, Cardiology, Hematology, Oncology, Orthopedic Imaging, Others
By End-User: Hospitals and Healthcare Providers, Pharmaceuticals and Biotechnology Companies, Healthcare Payers, Others
Global Growth Regions:
⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)
Benefits of the Report:
Chapter 1: Opens the report with a comprehensive market overview, highlighting key segments by region, product type, and application. It presents a clear snapshot of market size, growth potential by segment, and both short- and long-term outlook.
Chapter 2: Showcases the most impactful insights, uncovering the emerging trends and disruptive forces shaping the industry's future.
Chapter 3: Delivers an in-depth competitive landscape analysis of the Artificial Intelligence in Medical Devices market, covering revenue shares, strategic moves, and the latest mergers & acquisitions.
Chapter 4: Features detailed profiles of leading players, including their revenue streams, profit margins, product portfolios, and key milestones.
Chapters 5 & 6: Present a granular breakdown of regional and country-level revenue performance, offering a precise view of market size, opportunities, and development prospects worldwide.
Chapter 7: Analyzes market segmentation by product type, revealing the growth potential of each category and spotlighting high-impact.
Chapter 8: Examines application-based market growth, identifying the fastest-expanding sectors and lucrative opportunities for expansion.
Chapter 9: Maps the entire industry supply chain, providing insights into upstream and downstream activities for a complete market perspective.
Chapter 10: Concludes with key findings and actionable takeaways, guiding stakeholders toward strategic decisions and future growth opportunities.
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Q1: How Large is the Artificial Intelligence in Medical Devices Market?
A: The Artificial Intelligence in Medical Devices Market was valued at US$ 21.50 billion in 2023 and is expected to experience substantial growth, reaching US$ 228.98 billion by 2031.
Q2: How fast is the Artificial Intelligence in Medical Devices Market growing?
A: The Market is experiencing strong growth and is projected to expand at a CAGR of 34.7% from 2025 to 2032.
Q3: Which Region Leads Artificial Intelligence in Medical Devices Market growth?
A: Asia-Pacific leads the Artificial Intelligence in Medical Devices Market with fastest growth.
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