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Critical Gap in AI Radiology Safety: Software Updates Lag Behind Device Failures
A comprehensive analysis of 956 FDA-approved radiology AI devices reveals a troubling disconnect: while software defects drive most failures, manufacturers rarely implement corresponding safety updates or maintain integrated risk management systems. Original paper: The absence of full lifecycle risk management for AI-based medical devices in radiology. — NPJ Digital Medicine, May 2026. 📄 Read the article
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By MedAI DigestA comprehensive analysis of 956 FDA-approved radiology AI devices reveals a troubling disconnect: while software defects drive most failures, manufacturers rarely implement corresponding safety updates or maintain integrated risk management systems. Original paper: The absence of full lifecycle risk management for AI-based medical devices in radiology. — NPJ Digital Medicine, May 2026. 📄 Read the article