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ANALYZING ADVERSE EVENTS OF FDA APPROVED AI-ENABLED MEDICAL DEVICES FOR RISK-AWARE DEVELOPMENT Yang, Annie; Özcan Top, Özden; Department of Information Systems (2025-11-26) There is increased research interest and development of artificial intelligence (AI) in various industries, especially in healthcare. Regulatory bodies are evolving to promote patient safety and product efficacy. As theories and regulations advance to guide AI development, there is a need to continuously improve by understanding the adverse events of AI-enabled medical devices. Adverse events can reflect inadequacies in the AI system life cycle processes. AI-enabled medical devices life cycle processes must...
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