Most of AI-Enabled Medical Device Recalls Came From Public Firms, Says JAMA
Healthcare Brew
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Contributed by: Kate Gamble
Summary
The FDA has seen a dramatic rise in AI-enabled medical devices, increasing from under 700 in 2023 to 1,247 by August 2024, raising concerns due to a corresponding rise in recalls. A JAMA research letter highlights that 60 of these AI devices accounted for 182 recall events, predominantly affecting publicly traded companies, which faced a 92% recall rate compared to 53% for private firms. This pattern suggests that the pressure from investors for rapid innovation may compromise thorough vetting, leading to recalls primarily due to diagnostic errors and hazards that impact patient safety. The findings underscore the need for stricter validation practices in the FDA clearance process, particularly for devices approved via the less rigorous 510(k) pathway.
