News & Analysis

Curated news and analysis on clinical trials, drug approvals, and medical research.

Researchers outline guidance for safer AI-enabled medical devices

A publication in NEJM AI outlined seven human factors-related risks for AI-enabled medical devices and called for clearer workflows, training, fallback options and post-market monitoring. The analysis said current approval requirements only partially address these risks, while separate evidence cited persistent accuracy and verification problems in medical AI use.

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