AI Could Cut Medical Device Recalls by Nearly a Third, Study Finds
News Release, September 21, 2026
Most medical devices do not hit the market through rigorous safety testing but by being deemed similar enough to something already approved—the “predicate” device through a mechanism known as the FDA’s 510(k) pathway. But similar is not a synonym for safe. While the assumption may be that substantial equivalence is a reasonable stand-in for a safety review, a share of devices cleared with this method still get recalled, and the FDA spends valuable time reviewing devices the same way, regardless of how risky it is on paper.
