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Study
More than algorithms: an analysis of safety events involving ML-enabled medical devices reported to the FDA.
May 3, 2023
Lyell D, Wang Y, Coiera E, et al. J Am Med Inform Assoc. 2023;30(7):1227-1236.
Patients and healthcare providers rely on devices that use artificial intelligence or machine learning in diagnostics, treatment, and monitoring. This study utilizes adverse event reports submitted to the FDA's Manufacturer and Use Facility Device Experience (MAUDE) database for machine learning-enabled devices. Mammography was implicated in 69% of reports, and the majority were near-miss events.
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