AIMC Topic: Medical Device Recalls

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Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning-Enabled Medical Device Recalls in the United States: Implications for Future Governance.

JMIR medical informatics Jul 11, 2025
BACKGROUND: Artificial intelligence/machine learning (AI/ML) has revolutionized the health care industry, particularly in the development and use of medical devices. The US Food and Drug Administration (FDA) has authorized over 878 AI/ML-enabled medi...
Humans Artificial Intelligence Machine Learning United States United States Food and Drug Administration Device Approval Medical Device Recalls
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Software-related recalls in computer-assisted hip and knee arthroplasty.

International orthopaedics Jan 13, 2023
PURPOSE: Computer-assisted arthroplasty supports the surgeons in planning, simulating, and performing the replacement procedure, using robotic or navigation technologies. However, the safety of the technology has not been widely ascertained. Food and...
Humans Software Computers Robotics Surgery, Computer-Assisted Arthroplasty, Replacement, Knee Medical Device Recalls
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A Machine Learning Algorithm to Predict Medical Device Recall by the Food and Drug Administration.

The western journal of emergency medicine Jan 1, 2025
INTRODUCTION: Medical device recalls are important to the practice of emergency medicine, as unsafe devices include many ubiquitous items in emergency care, such as vascular access devices, ventilators, infusion pumps, video laryngoscopes, pulse oxim...
Humans Machine Learning Algorithms Sensitivity and Specificity United States United States Food and Drug Administration Medical Device Recalls
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