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PubMed

Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study.

PMID: 41032887 ·

Marlen Peseke, Ilja Michaelis, Ornella Tangila Kayembe, Majella Geraghty, Ali McDonnell, Franco Luigi Zurlo, Zoe Sophie Oftring, Nicolas Martelli, Tom Melvin, Sebastian Kuhn

JournalJournal of medical Internet research
Year
PMID41032887

Abstract

Early feasibility studies (EFSs) are small-scale clinical investigations conducted during the early development of medical devices to assess initial safety and performance, especially when bench or in-silico testing is insufficient. While EFSs are well established for hardware devices, their application to digital health technologies (DHTs) including artificial intelligence (AI)-enabled medical devices remains limited. The rapidly evolving regulatory landscape, including the European Union Medic

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