Recently published in Nature Medicine, the study found that nearly 43 percent of the 521 AI health devices approved by the FDA between 2016 and 2022 lack publicly available clinical validation data showing they were tested on real patient data. This means that almost half of these tools were not necessarily "trained" on actual patient cases, sparking concerns about their performance in real-world medical settings.
The researchers involved in the study are calling for more transparency and better standards in the development and approval of AI-powered medical devices. They argue that clearer guidelines are needed to determine which devices are truly effective and which might need more testing.
Lead author Sammy Chouffani El Fassi, a medical student from the University of North Carolina at Chapel Hill, emphasized the lack of a standard for understanding the quality and reliability of these devices...<<<Read More>>>...
