4 takeaways from the FDA’s first digital health advisory committee

MedTech Dive December 12, 2024
Elise Reuter

Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology.

The Food and Drug Administration grappled with questions about how to regulate generative artificial intelligence in medical devices at its first digital health advisory committee meeting.

To date, the agency has authorized nearly 1,000 AI-enabled medical devices, but none of those devices use adaptive or generative AI. However, the technology is being explored in other healthcare applications not regulated by the FDA, such as generating clinical notes for physicians.

“For us to be most effective in our jobs as protectors of public health, it’s essential that we embrace these groundbreaking technologies, not only to keep pace with...

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