MedCity News September 8, 2024
As the FDA continues its work to ensure that AI is deployed safely within healthcare, there are a couple prevalent issues that frequently pop up, said Luke Ralston, one of the agency’s reviewers.
“The bottom line is that AI regulation is really about transparency. We don’t know everything.”
Those words were spoken by Luke Ralston — who has been a biomedical engineer and scientific reviewer at the FDA for nearly two decades — during a presentation last week at the Heart Rhythm Society’s HRX conference in Atlanta. The FDA still views AI regulation as an evolving science that is highly specific to each device and its intended use, he said.
As the FDA continues its work to ensure...
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