Regulatory science for AI-based software as a medical device in computational pathology and biomarker-driven drug development.

Yael Liebes-Peer¹, Shlomo Czeisler¹, Rachel Broderick¹, Manuela Vecsler¹, Yair Heller¹, Chaim Linhart¹, Joseph Mossel¹, Jochen K Lennerz¹

¹Ibex Medical Analytics LTD, Tel Aviv, Israel.

PubMed PMC DOI PDF

Abstract

BACKGROUND: Artificial intelligence (AI)-enabled software is increasingly integrated into digital and computational pathology, driving new regulatory and quality management requirements that extend beyond traditional laboratory practice and classical medical-device oversight. Practical, experience-based guidance on balancing development agility with global regulatory readiness remains limited for…

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