MedTech Dive September 9, 2024
About 43% of all AI-enabled devices cleared or approved by the FDA through 2022 were missing validation data, and only 28% were tested prospectively, according to a Nature Medicine study.
More than 40% of all artificial intelligence tools cleared or approved by the Food and Drug Administration lack clinical evidence, according to an article recently published in Nature Medicine.
Researchers at the University of North Carolina School of Medicine found that 226 AI-enabled medical devices authorized by the FDA between 1995 and 2022 were missing clinical validation data. The figure represents about 43% of all 521 devices the agency authorized during this period.
“The FDA and medical AI developers should publish more clinical validation data and prioritize prospective...
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