AI Is Forcing FDA Medical Device Rules To Evolve

By Mildred Segura, Maryanne Woo and Christopher Butler (April 30, 2019, 4:52 PM EDT) -- If the promise of adaptive artificial intelligence (sometimes called machine learning) is to be achieved in the medical area, the U.S. Food and Drug Administration's regulation of medical devices is going to have to graduate from geometry to calculus. By its nature, machine learning changes the details of its output constantly....

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