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Jul 10, 2024

Artificial Intelligence/Machine Learning Medical Device Market: New Report Forecasts Booming The Market

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Artificial Intelligence/Machine Learning Medical Device Market Size, Share & Trends Analysis Report By Product Type (System/Hardware, Software-as-a-Medical Device), Clinical Area (Radiology, Diagnostic Assistance, Imaging, Image Reconstruction, Cardiology, Electrocardiography-Based Arrhythmia Detection, Hemodynamics and Vital Signs Monitoring, Hematology,)- Market Outlook and Industry Analysis 2031"


The Global Artificial Intelligence/Machine Learning Medical Device Market is valued at US$ 5.08 billion in 2023, and it is expected to reach US$ 25.8 billion by 2031, with a CAGR of 23.1% during the forecast period of 2024-2031.


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Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing the medical device industry, enabling innovative technologies that enhance diagnosis, treatment, and patient care. AI-enabled medical devices, capable of learning from vast datasets, assist healthcare providers in various critical tasks. These devices automate image analysis for disease detection, predict patient outcomes, optimize treatment plans, and monitor patient health remotely. Key applications include automating radiology and cardiology image analysis, empowering wearable sensors for remote patient monitoring, and enhancing surgical precision in minimally invasive procedures through advanced planning and guidance systems.


As of March 2024, the FDA has authorized over 880 AI-enabled medical devices, signaling rapid adoption within the industry. Despite this growth, critical challenges such as data privacy concerns, algorithm bias, and regulatory intricacies persist. However, the rising demand for AI/ML solutions in radiology, cardiology, and wearable technology, supported by governmental initiatives, underscores their transformative impact on healthcare.


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


Market Dynamics:


The AI solutions market benefits significantly from a diverse ecosystem comprising established companies and startups developing innovative healthcare applications. This landscape includes a growing adoption of AI in radiology and cardiology, driven by its capability to reduce waiting times and alleviate healthcare system pressures. Concurrently, the increasing use of wearable sensors is fueling demand for AI-enabled medical devices tailored for remote patient monitoring and home-based care. Government initiatives further bolster this trend by supporting research and development in AI-powered medical technologies


Notably, educational institutions are also recognizing this potential; for instance, the Indian Institute of Science (IISc) in Bengaluru has partnered with the Karnataka government to launch ARTPARK, a $100 million venture fund aimed at investing in AI and robotics startups, highlighting collaborative efforts to advance technological innovation in healthcare. These insights are supported by data from Invest India, underscoring the strategic initiatives driving growth in the sector.



Concerns persist in the adoption of AI in healthcare due to issues like data sharing transparency and cybersecurity risks. Bias in AI algorithms pose challenges in ensuring reliable diagnoses, impacting confidence in AI-enabled solutions. Regulatory hurdles, including evolving frameworks for algorithm change protocols and validation of continuously learning algorithms, further complicate the integration of AI in medical devices.


Regional Trends:

The North American market, particularly the U.S., is experiencing a significant uptick in healthcare IT solutions adoption, driving the growth of AI/ML medical devices in the region. This trend is supported by ample funding opportunities for developing AI capabilities, which further propels the expansion of AI/ML medical devices. Additionally, North America benefits from a well-established healthcare infrastructure that facilitates the integration of advanced technologies like AI/ML devices. Moreover, the region, led by the U.S. FDA, has streamlined regulatory processes, enabling quicker approvals for AI/ML-enabled medical devices compared to other global regions. This regulatory efficiency has solidified North America's leadership in advancing AI/ML technologies in healthcare.


Recent Developments:

  • In April 2024, Medtronic introduced 14 new AI algorithms alongside its Touch Surgery Live Stream digital offering, enhancing post-operative analysis capabilities. These AI tools provide surgical insights for laparoscopic and robotic-assisted surgeries.
  • In June 2024, NANO-X IMAGING LTD subsidiary Nanox AI Ltd. has integrated FDA 510(k)-cleared AI solutions into USARAD Holdings INC's Second Opinions platform. This enhances online medical consultations by connecting patients with specialists for second opinions in radiology, neurology, oncology, and orthopedic surgery, focusing on early detection of chronic conditions in chest and abdominal CT scans.
  • In January 2024, Hyperfine, Inc. launched the eighth generation of its Swoop® system software, featuring AI-powered diffusion-weighted imaging (DWI) denoising. Cleared by the FDA in October 2023, the software has been gradually rolled out at selected sites through a limited market release. This update enhances image quality and introduces user-friendly features such as real-time assistance for precise patient positioning and an optimized image upload process.


Segmentation of Artificial Intelligence/Machine Learning Medical Device Market-


By Product Type:

  • System/Hardware
  • Software-as-a-Medical Device

By Clinical Area:

  • Radiology
  • Diagnostic Assistance
  • Imaging
  • Image Reconstruction
  • Cardiology
  • Electrocardiography-Based Arrhythmia Detection
  • Hemodynamics and Vital Signs Monitoring
  • Hematology
  • Others


By Region-

North America-

  • The US
  • Canada
  • Mexico


  • Germany
  • The UK
  • France
  • Italy
  • Spain
  • Rest of Europe


  • China
  • Japan
  • India
  • South Korea
  • Southeast 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