FDA-cleared medical AI rarely tested for real-world benefits

A new analysis of 1,357 artificial intelligence–based medical devices cleared by the U.S. Food and Drug Administration finds that only three have been evaluated for whether they actually improve patients’ health outcomes. The study, published in PLOS Digital Health, raises concerns about the evidence base underpinning clinical AI tools that are already in routine use and calls for more rigorous post-market evaluation of their real-world impact.