AI Medical Devices Lacking Clinical Trials Face More Recalls
A study found that AI devices cleared via the FDA's 510(k) pathway were more likely to be recalled for safety issues.
A Potential Regulatory Gap
A study highlighted on September 16, 2025, by the American Hospital Association found that AI-enabled medical devices cleared by the U.S. Food and Drug Administration through its less stringent 510(k) pathway were more likely to be recalled. The research, originally published in the JAMA Health Forum, raises concerns about the post-market safety of artificial intelligence in healthcare.
The study examined 950 AI medical devices authorized by the FDA through November 2024. It found that 60 of them were associated with 182 separate recall events. The most common causes for the recalls were diagnostic or measurement …
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