AI could cut medical device recalls by nearly a third, study finds
Most medical devices do not enter 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 substant
<p>Most medical devices do not enter 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 substant</p>