Author

I. Shiri

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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. · npj Digital Medicine · 0 citations

Open access Aug 2026

Multimodal artificial intelligence-based long-term mortality prediction after transcatheter aortic valve implantation: a multicentre development, validation, and testing study.

The authors' explainable, multimodal AI-based model for predicting long-term outcomes in the TAVI population substantially outperformed conventional risk scores and showed robust generalisability across diverse TAVI populations and clinical settings.

I. Shiri, D. Tomii, Giovanni Baj et al. · The Lancet Digital Health · 0 citations