Health
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.
Summary
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.
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