In New Guidance, FDA Says AI Tools to Warn of Sepsis Should Be Regulated as Devices

September 27, 2022

(STAT News) – The U.S. 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. (Read More)