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Enrico G Caiani on Muck Rack

Enrico G Caiani

As seen in: Nature, MDPI, The Lancet
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Articles

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

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By Yijun Ren, Daniel Windecker, Isaac Shiri, Christoph Gräni, Alan Fraser, Enrico G Caiani, George CM Siontis
| Nature Verified
Abstract 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 a publicly available European database (Health AI Register) and FDA sources using Kaplan–Meier methods and Cox models.
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CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software - npj Digital Medicine

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By Frank Rademakers, Elisabetta Biasin, Nico Bruining, Enrico G Caiani, Gearóid McGauran, Gearóid O’Connor
| Nature Verified
Abstract The European CORE–MD consortium (Coordinating Research and Evidence for Medical Devices) proposes a score for medical devices incorporating artificial intelligence or machine learning algorithms. Its domains are summarised as valid clinical association, technical performance, and clinical performance.
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Device Orientation Independent Human Activity Recognition Model for Patient Monitoring Based on Triaxial Acceleration

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By Gabriele Papini, Enrico G Caiani, Sara Caramaschi
| MDPI
This is an early access version, the complete PDF, HTML, and XML versions will be available soon. Open AccessArticle by Sara Caramaschi 1,2,*,†, Gabriele B. Papini 3,4,† and Enrico G.
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