Can AI Become Your Doctor? FDA Regulation, Medical Devices & the Future of Healthcare
Could artificial intelligence become your doctor someday? In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Alex Friedman, a regulatory affairs expert with deep experience in medical devices, FDA submissions, quality systems, and AI-enabled Software as a Medical Device.
Alex helps unpack one of the most important questions in healthcare innovation: when does software become a regulated medical device, and what happens when AI begins influencing clinical decisions?
The conversation moves from classic medical device classifications to 510(k) submissions…
The skinny
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