MedTech Dive January 22, 2025
New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.
Artificial intelligence was a topic of focus for the medical device industry in 2024.
Companies including GE Healthcare, Medtronic and Dexcom touted new AI features, and others like Stryker and Quest Diagnostics added AI assets through M&A. Meanwhile, conversations about regulations and generative AI, models that are trained to create new data including images and text, dominated medtech conferences.
The Food and Drug Administration recently clarified what information it wants to see in future submissions as the number of AI-enabled devices authorized by the agency has eclipsed 1,000. The FDA still has not authorized...
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