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PubMed

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

PMID: 42436740 ·

Yael Liebes-Peer, Shlomo Czeisler, Rachel Broderick, Manuela Vecsler, Yair Heller, Chaim Linhart, Joseph Mossel, Jochen K Lennerz

JournalJournal of pathology informatics
Year
PMID42436740

Abstract

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 biomarker developers and translational pathologists navigating the convergence of AI governance, cybersecurity,

Official Source

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