FDA Commissioner Dr. Marty Makary announced Tuesday that wearable devices providing non-medical-grade information will not be subject to FDA regulation, as the agency moves to clarify its approach to digital health and artificial intelligence."We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation," Makary told "Varney & Co." "The only stipulation is if they make claims of something being medical grade, like a clinically appropriate, clinical grade blood pressure measurement. We don'...

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