AI could cut medical device recalls by nearly a third, study finds

Most aesculapian devices bash not participate the marketplace done rigorous information investigating but by being deemed akin capable to thing already approved—the "predicate" device—through a mechanics known arsenic the FDA's 510(k) pathway. But akin is not a synonym for safe. While the presumption whitethorn beryllium that important equivalence is simply a tenable stand-in for a information review, immoderate devices cleared with this method are inactive recalled, and the FDA spends invaluable clip reviewing devices the aforesaid way, careless of however risky they look connected paper.