A lot of artificial intelligence tools in medicine pitch themselves as breakthroughs. But there are some that can put some extra oomph behind that claim. Since 2016, the Food and Drug Administration has handed out “breakthrough” designation to more than 1,200 devices, including many powered by AI.
The designation comes with priority FDA review, with the goal of enabling innovative devices to reach patients and hospitals quicker. But what does the agency count as a breakthrough, especially in clinical AI, a decade after it established the Breakthrough Designation Program?
An analysis of STAT’s Breakthrough Device Tracker — which tracks all publicly available breakthrough designations, not just those the FDA has authorized — shows that the agency appears to be prioritizing big-picture, multi-problem AI solutions. Algorithms that simply improve a doctor’s capabilities are no longer enough: AI breakthroughs increasingly solve problems that physicians simply can’t, like detecting multiple cancers from a single image, or predicting the risk of dying from cancer or heart failure.
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