The Food and Drug Administration on Tuesday published a list of artificial intelligence tools that should be regulated as medical devices, in some cases appearing to expand its oversight of previously unregulated software products.
In a new final guidance for industry, the agency specified that tools designed to warn caregivers of sepsis, a life-threatening complication of infection, should come under regulatory review. Health software vendors have been selling tools designed to flag the condition for years without obtaining clearance from the FDA.
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