AI-enabled medical devices with limited pre-market validation are more likely to be recalled after FDA clearance.
Key Details
- 1AI-enabled device recalls are more common among those lacking prospective human validation prior to FDA 510(k) clearance.
- 2Most AI medical devices are cleared without requiring prospective clinical testing.
- 3Study reviewed all U.S. recalls of AI-enabled devices between Nov. 15–30, 2024.
- 4Validation method (none, retrospective, or prospective) was a notable factor influencing recall likelihood.
- 5Recalls were categorized into errors such as diagnostic, measurement, and functional issues.
Why It Matters
These findings highlight the inadequacy of current FDA pathways to ensure AI device reliability and safety in clinical environments. For radiology professionals and developers, the results underscore the critical importance of robust validation before market approval.
Source
Health Imaging
Related News
•AuntMinnie
AI Enhancement Dramatically Improves Quality of Suboptimal Chest CTs
AI-powered image enhancement significantly boosts the diagnostic quality of suboptimal chest CT and CTPA studies.
•AuntMinnie
AI Enables Safe 75% Gadolinium Reduction in Breast MRI Without Losing Sensitivity
AI-enhanced breast MRI with a 75% reduced gadolinium dose maintained diagnostic sensitivity comparable to full-dose protocols.
•Cardiovascular Business
Deep Learning AI Model Detects Coronary Microvascular Dysfunction Via ECG
A new AI algorithm rapidly detects coronary microvascular dysfunction using ECGs, with validation incorporating PET imaging.