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Understanding FDA Breakthrough Devices in Clinical AI
The definition of a 'breakthrough' medical device by the FDA is evolving with advancements in clinical AI. This shift raises questions about what qualifies as a significant innovation in the healthcare sector.
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What happened
The definition of a 'breakthrough' medical device by the FDA is evolving with advancements in clinical AI.
Why it matters
This shift raises questions about what qualifies as a significant innovation in the healthcare sector.