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.
Sepsis, which kills more than 200,000 people in the U.S. annually, is particularly difficult to detect. Several companies have developed AI tools to predict which patients are most likely to develop the condition, in a bid to help hospitals speed the delivery of antibiotics and save more lives.
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