3 new AI-enabled FDA ‘Breakthrough Devices’: an Alzheimer’s-detecting retinal scanner, a kidney disease diagnostic & more

(By Andrea Park for Becker’s Hospital Review)

Since the beginning of the month, the FDA has granted several artificial intelligence-powered health IT products “Breakthrough Device” status, which does not indicate safety approval, but designates a product as potentially life-saving and fast-tracks its development, testing and approval process.  Continue reading article here…

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