Clinical Evidence and FDA Recalls of Artificial Intelligence-Enabled Medical Devices.
PMID: 42275062 ·
Yijun Ren, Yi Zheng, Daniel Windecker, Alan G Fraser, George C M Siontis, Enrico G Caiani
JournalJAMA network open
Year
PMID42275062
Abstract
Artificial Intelligence (AI)-enabled medical devices present new safety challenges related to algorithmic complexity and evolving performance. Identifying device characteristics that influence recalls would be essential to caution against premature, widespread clinical deployment and to suggest increased surveillance. To test the hypothesis that AI-enabled medical devices lacking sufficient clinical evidence at approval have a higher hazard of recall. This retrospective cohort study included AI-
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