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

An analysis of 1,357 artificial intelligence-based medical devices authorized by the U.S. Food and Drug Administration found that only three had been evaluated for their impact on patient-centered outcomes such as mortality, stroke, hospitalizations, or quality of life. The authors argue that the rapid deployment of clinical AI is not being matched by rigorous clinical trials, raising concerns about how these tools affect real-world care.