Artificial Intelligence/Machine Learning Medical Device Market Growth Fueled by Rising Demand for Accurate Diagnostics and Personalized Care

The Artificial Intelligence/Machine Learning Medical Device Market Size is valued at 6.10 Billion in 2024 and is predicted to reach 52.09 Billion by the year 2031 at a 24.1% CAGR during the forecast period for 2024-2031.

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Latest Drivers Restraint and Opportunities Market Snapshot:
Key factors influencing the global artificial intelligence/machine learning medical device market are:
• Increasing demand for more accurate diagnosis
• Increasing the accessibility of health data
• Advancements in machine learning

The following are the primary obstacles to the artificial intelligence/machine learning medical device market's expansion:
• High initial investment
• Intricate regulatory approval procedures
• Rising data privacy issues

Future expansion opportunities for the global artificial intelligence/machine learning medical device market include:
• Increasing integration of AI
• Growing demand for efficiency and automation in medical imaging
• Increasing investments in the development of digital health

Key Industry Insights & Findings from the Report:
• The technological advancements and the growing need for precise and effective diagnosis.
• The market for artificial intelligence/machine learning medical devices is driven by the growing availability of health data, enhanced patient outcomes, rapid technology advancements, and strategic investments in digital health innovation.
• North America dominated the market and accounted for a revenue share of global revenue in 2023.
• One of the significant concerns restraining industry growth is the required high initial investment and rising data privacy issues.

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Market Analysis:
The global market for medical devices leveraging artificial intelligence (AI) and machine learning (ML) is poised for substantial growth, driven by the technologies' capacity to improve diagnostic precision and support personalized therapeutic strategies. AI and ML facilitate the rapid and accurate analysis of large, complex datasets, enabling early disease detection and informed clinical decision-making.

The deployment of AI and ML across imaging systems, robotic surgical platforms, and wearable medical devices has shown significant potential to enhance operational efficiency and improve patient outcomes. Furthermore, growing investments in digital health innovations, coupled with regulatory frameworks that promote technology adoption, are contributing to market expansion. Collectively, these trends equip healthcare providers with actionable, data-driven insights, underscoring the transformative role of AI- and ML-enabled devices within the global medical device sector.

List of Prominent Players in the Artificial Intelligence/Machine Learning Medical Device Market:
• CellaVision AB;
• Canon Inc.;
• Clarius Mobile Health Corp.
• General Electric Company;
• Aidoc Medical, Ltd.
• Koninklijke Philips N.V.,
• Hyperfine Inc.,
• Nanox.AI Ltd.,
• Medtronic Plc.,
• Page.AI,
• Koninklijke Philips N.V.
• Siemens Healthineers AG
• Tempus
• Shanghai United Imaging Healthcare Co., Ltd.
• Viz.ai, Inc.
• 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

Recent Developments:
• In February 2025, Longeviti Neuro Solutions, a neurotechnology company that provides cutting-edge platforms for complex brain surgeries, and Clarius Mobile Health, a leading supplier of high-resolution wireless ultrasound systems, will collaborate to give neurosurgeons access to wireless ultrasound scanners and sonolucent cranial implants, making them a safer and more affordable alternative to traditional implants.
• In June 2024, Health Canada approved the Clarius OB AI fetal biometric assessment tool, which automatically determines fetal age, weight, and growth intervals. Clarius Mobile Health is a major provider of high-definition handheld medical devices.
• September 2024, Canon Inc. announced that the CXDI-Pro series of wireless digital radiography devices, which include the CXDI-703C Wireless sensor unit, will be available in markets outside of Japan1. These devices are perfect for a wide range of applications in medical treatment facilities.

Artificial Intelligence and Machine Learning in Medical Devices - Market Dynamics
Market Drivers: Increasing Demand for High-Precision Diagnostics
The AI- and ML-enabled medical device market is primarily propelled by the rising demand for accurate and reliable diagnostic solutions. Healthcare providers are increasingly adopting advanced technologies that deliver timely, actionable insights, thereby reducing diagnostic errors and enhancing clinical outcomes. Additionally, significant investments in AI and ML research and development are accelerating the adoption of these technologies, particularly as early disease detection and personalized medicine emerge as strategic priorities in healthcare, further supporting market growth.

Challenges: Complex and Dynamic Regulatory Environment
Market growth is moderated by a complex and continuously evolving regulatory landscape. Manufacturers must adhere to stringent safety and performance standards, conduct extensive clinical validations, and demonstrate the reliability of large datasets to secure regulatory approvals. These requirements often involve substantial financial resources and extended timelines, potentially delaying the commercialization of innovative solutions. Smaller companies, in particular, may encounter significant difficulties navigating regulatory complexities, which can impede innovation and limit market access.

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North America Is Expected To Grow With The Highest CAGR During The Forecast Period
The North American market for AI- and ML-enabled medical devices is projected to secure a significant share of global revenue and register robust growth at a notable compound annual growth rate (CAGR) over the forecast period. This expansion is driven by the region's extensive adoption of advanced healthcare technologies, substantial investments in digital health research and development, and a well-established healthcare infrastructure.

Additionally, clearly defined regulatory frameworks, strategic collaborations among industry stakeholders, and a comprehensive network of healthcare facilities support the efficient deployment and integration of AI-powered medical solutions. Rising demand for personalized therapies, improved diagnostic accuracy, and remote patient monitoring further bolsters market growth, positioning North America as a key leader in the global AI- and ML-enabled medical device industry.

Segmentation of Artificial Intelligence/Machine Learning Medical Device Market-
By Product Type-
• System/Hardware
• Software-as-a-Medical Device
By Application-
• Radiology
• Cardiology
• Hematology
By Region-
North America-
• The US
• Canada
• Mexico
Europe-
• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe
Asia-Pacific-
• China
• Japan
• India
• South Korea
• South East Asia
• Rest of Asia Pacific
Latin America-
• Brazil
• Argentina
• Rest of Latin America
Middle East & Africa-
• GCC Countries
• South Africa
• Rest of Middle East and Africa

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This release was published on openPR.