The U.S. Food and Drug Administration (FDA) has announced a significant milestone in the field of artificial intelligence and machine learning (AI/ML) in healthcare. As of August 7, 2024, the agency has authorized a total of 950 AI/ML-enabled medical devices for use in the United States.
This remarkable figure underscores the rapid advancement and adoption of AI technologies in the medical field. The FDA has been diligently tracking and evaluating these innovative devices, which span across various medical disciplines.
To provide transparency and inform the public, the FDA has compiled a comprehensive list of these authorized AI/ML-enabled devices. This list, which is regularly updated, includes detailed information such as the device name, manufacturer, date of approval, and its primary intended use.
The FDA emphasizes that all listed devices have undergone rigorous evaluation to ensure they meet the agency’s stringent safety and effectiveness standards. This assessment process includes a thorough review of each device’s performance, with particular attention paid to the diversity of study populations used in device testing.
While the list is extensive, the FDA notes that it may not be exhaustive. The agency encourages stakeholders to provide feedback or ask questions about the list via email at [email protected].
This development marks a significant step forward in the integration of AI and ML technologies into healthcare, potentially improving diagnostic accuracy, treatment planning, and patient outcomes across a wide range of medical specialties.
As the field continues to evolve rapidly, the FDA’s ongoing efforts to monitor and regulate these advanced medical devices will play a crucial role in ensuring their safe and effective use in clinical practice.
Quellen:
[1] artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices
[2] Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical D https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices
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