Medscape August 30, 2024
Forty-three percent of the 521 artificial intelligence (AI) health devices authorized by the US Food and Drug Administration (FDA) between 2016 and 2022 lack publicly available clinical validation showing they were tested using real patient data, a new study found.
The study, from the University of North Carolina (UNC) at Chapel Hill, highlights an urgent need for more public data and clearer standards around AI medical devices, the researchers say. And they’re calling for clinicians to get involved.
“The number of devices that we found clinical validation data on — a lot of people think, oh, that’s the big news,” said lead author Sammy Chouffani El Fassi, an MD candidate at the UNC School of Medicine and research scholar...
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