米食品医薬品局（FDA）が公開している「米国内で合法的に市販されているAI医療機器リスト」

Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

October 19, 2023 update: 171 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices were added to the list below. Of those newly added to the list, 155 are devices with final decision dates between August 1, 2022, and July 30, 2023, and 16 are devices from prior periods identified through a refinement of methods used to generate this list. 

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Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices | FDA