What the FDA wants you to know about Pre-Cert

It’s been a busy month for digital health over at the FDA. In addition to a warning for patients hacking insulin pumps, the agency issued a handful of clearances—from AliveCor’s six-lead smartphone ECG to two AI tools to make radiologists’ jobs easier.

The increase in approval for AI products is no coincidence—the FDA is evolving its oversight approach, and wants to do so in partnership with innovators. In our newest podcast episode, we caught up with the FDA’s Bakul Patel and portfolio company Enzyme’s Jared Seehafer to get an update on Pre-Cert and how the digital health community can provide input on the agency’s proposed framework for regulating AI/ML in healthcare. Learn more and listen here.


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