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Sponsored Artificial Intelligence: A Modern Approach, Global Edition Artificial Intelligence: A Modern Approach, Global Edition

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Yijun Ren

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Review Open access Aug 2026

Delays between CE mark and FDA regulatory approval of AI-enabled software for radiology

Artificial intelligence (AI)-enabled radiology software requires regulatory authorisation before marketing in Europe (EU) and the United States, but cross-jurisdictional approval sequencing remains poorly characterised. We analysed 239 AI-enabled radiology software devices with CE marking and/or FDA clearance from...

Yijun Ren, D. Windecker, I. Shiri et al. · 0 citations

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