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- FDA clears Roche and Lilly Alzheimer’s blood tests, while Regenxbio gene therapy trial halted againThe U.S. Food and Drug Administration announced it has granted clearance for blood-based diagnostic tests for Alzheimer’s disease developed by Roche and Eli Lilly. The clearances allow the compani…
- FDA asks industry input on competency-based rules for generative AI medical devicesThe FDA announced it is soliciting comments on a proposed competency-based framework for overseeing medical devices that incorporate generative artificial intelligence. The agency says the approac…