Early Recalls and Clinical Validation Gaps in Artificial Intelligence–Enabled Medical Devices

This cross-sectional study examines whether lack of clinical validation and publicly traded manufacturer status were associated with recalls of artificial intelligence–enabled medical devices that had been cleared by the US Food and Drug Administration.

Corresponding Author: Tinglong Dai, PhD, Carey Business School, Johns Hopkins University, 100 International Dr, Baltimore, MD 21202 (dai@jhu.edu).

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