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- FDA grants de novo clearance to Powerful Medical’s AI tool for detecting severe heart attacks on EKGsThe U.S. Food and Drug Administration issued a de novo classification for Powerful Medical’s AI algorithm that analyzes electrocardiograms to identify severe heart attacks. This clearance allows th…
- FDA leadership stabilizes under new CBER and CDER heads and appoints first AI deputy commissionerAt the Food and Drug Administration, Karim Mikhail and Michael Davis have been confirmed as the permanent heads of the Center for Biologics Evaluation and Research and the Center for Drug Evaluatio…