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Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use
41
Zitationen
7
Autoren
2025
Jahr
Abstract
In this cross-sectional study, clinical performance studies at the time of approval were reported for approximately half of AI-enabled medical devices, yet the information was often insufficient for a comprehensive assessment of their clinical generalizability, emphasizing the need for ongoing monitoring and regular re-evaluation to identify and address unexpected performance changes during broader use.
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