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The Food and Drug Administration has plans to make the database that houses medical device reports submitted to the agency more user friendly.June 24
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The American Medical Informatics Association wants the Food and Drug Administration to improve its conceptual approach to regulating medical devices that leverage self-updating artificial intelligence algorithms.June 11
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Agency is looking for volunteers planning to submit a De Novo Request or 510(k) submission to evaluate Pre-Cert working model.May 28
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Agency reports that unauthorized system resulted in an insulin overdose requiring medical intervention.May 20
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The Food and Drug Administration is proposing recommendations on how to better design studies to assess pregnancy outcomes in women exposed to FDA-regulated drugs and biological products.May 13
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A Mount Sinai Health System startup, seeking to commercialize an artificial intelligence-enabled clinical diagnostic for kidney disease, has been granted priority regulatory review by the Food and Drug Administration.May 3
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The Food and Drug Administration issued a warning on Wednesday that medical devices marketed for the diagnosis of a head injury that have not been reviewed by the agency might not be safe or effective.April 11
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The Food and Drug Administration is considering a new regulatory framework to promote the development of safe and effective medical devices that leverage artificial intelligence algorithms.April 3
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Scott Gottlieb, the U.S. Food and Drug Administration Commissioner, ending a tenure where he approved more drugs and pushed for sharp curbs on e-cigarettes.March 6
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Sentinel, which monitors FDA-approved drugs through active surveillance, is being enhanced to capture clinical data to better detect potential new safety problems.March 1
