Public Companies Account for 90% of AI Medical Device Recalls
A new study in JAMA Health Forum on September 1 found a strong link between publicly traded firms and AI device recalls.
A new study published on September 1, 2025, in JAMA Health Forum has raised significant concerns about the safety and reliability of AI-enabled medical devices (AIMDs), particularly those produced by publicly traded companies. The research found that while public companies manufactured just over half of the AIMDs cleared by the U.S. Food and Drug Administration, they were responsible for more than 90% of all recall events.
A "Lopsided" Problem
The study, conducted by researchers from Johns Hopkins and Yale, analyzed 950 AIMDs. It found that public company status was associated with a 5.9 times higher chance of a recall. …
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