Artificial Intelligence/Machine Learning Medical Device Market Opportunities Arise from Increasing Health Data Accessibility and Automated Workflows

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 expected to experience substantial growth, driven by their capacity to improve diagnostic precision and enable individualized treatment strategies. These advanced technologies facilitate the rapid and efficient processing of large, complex datasets, supporting early disease identification and informed clinical decision-making.

The deployment of AI and ML across imaging modalities, robotic surgical systems, and wearable medical devices has demonstrated significant potential in streamlining operational workflows and enhancing patient care outcomes. Additionally, growing investments in digital health innovations, coupled with regulatory frameworks that promote technology adoption, are further accelerating market expansion. Collectively, these advancements equip healthcare providers with actionable, data-driven insights, underscoring the transformative role of AI- and ML-enabled devices in 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: Rising Demand for Enhanced Diagnostic Precision
The expansion of the AI- and ML-enabled medical device sector is primarily fueled by the growing need for superior diagnostic accuracy. Healthcare providers are increasingly integrating advanced technologies capable of delivering timely, precise, and actionable patient insights. AI-driven devices, recognized for their high reliability, help minimize diagnostic errors and support improved clinical outcomes. Furthermore, significant investments in AI and ML research and development are accelerating the adoption of these technologies, particularly as early disease detection and personalized medicine become strategic priorities, thereby driving market growth.

Challenges: Complex and Evolving Regulatory Environment
Market development is constrained by intricate and continually evolving regulatory frameworks. Manufacturers must comply with stringent safety and performance standards, conduct comprehensive clinical validations, and demonstrate the reliability of extensive datasets to secure regulatory approvals. These requirements often involve substantial financial commitments and prolonged timelines, potentially delaying the introduction of innovative solutions. Smaller enterprises, in particular, face significant challenges in navigating these regulatory complexities, which can impede innovation and market access, thereby

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

Additionally, a comprehensive regulatory environment, strategic industry collaborations, and a strong network of healthcare facilities support the seamless adoption and integration of AI-driven medical solutions. The rising demand for personalized therapies, improved diagnostic accuracy, and remote patient monitoring further reinforces market growth, positioning North America as a leading hub in the global AI and ML medical device landscape.

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.