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FDA’s first Digital Health AdComm meeting mulls promises & perils of Generative AI

Amid continued rapid development of novel software products that present new opportunities in the health care space, FDA has yet to grant marketing authorization to a medical device incorporating artificial intelligence (AI)...more

FDA launches list of AI and machine learning-enabled medical devices

Yesterday, the U.S. Food and Drug Administration (FDA) shared online its list of artificial intelligence and machine learning (AI/ML)-enabled devices that are legally marketed in the U.S. (via 510(k) clearance, De Novo...more

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