Beyond detection: In the age of clinical AI, what counts as an FDA 'breakthrough' medical device?

Summary: Lots of medical artificial intelligence (AI) tools claim to be "breakthroughs." Since 2016, the FDA has given this special label to over 1,200 devices so they can reach patients faster. But what really counts as a breakthrough today? It is no longer enough for AI to just help a doctor do their job a little better. Now, the FDA wants AI that solves problems human doctors simply can't solve on their own. This includes things like finding several types of cancer in a single picture or predicting the risk of dying from heart failure.

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