Haftungsausschluss: Diese Website bündelt öffentlich verfügbare Daten aus offiziellen Quellen wie FDA, ClinicalTrials.gov, PubMed und SEC EDGAR nur zur allgemeinen Information. Sie stellt keine medizinische Beratung, Diagnose, Behandlungsempfehlung oder Anlageberatung dar.

PubMed

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

PMID: 41032887 ·

M, a, r, l, e, n, , P, e, s, e, k, e, ;, , I, l, j, a, , M, i, c, h, a, e, l, i, s, ;, , O, r, n, e, l, l, a, , T, a, n, g, i, l, a, , K, a, y, e, m, b, e, ;, , M, a, j, e, l, l, a, , G, e, r, a, g, h, t, y, ;, , A, l, i, , M, c, D, o, n, n, e, l, l, ;, , F, r, a, n, c, o, , L, u, i, g, i, , Z, u, r, l, o, ;, , Z, o, e, , S, o, p, h, i, e, , O, f, t, r, i, n, g, ;, , N, i, c, o, l, a, s, , M, a, r, t, e, l, l, i, ;, , T, o, m, , M, e, l, v, i, n, ;, , S, e, b, a, s, t, i, a, n, , K, u, h, n

ZeitschriftJournal of medical Internet research
Jahr
PMID41032887

Zusammenfassung

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

Offizielle Quelle

Auf PubMed ansehen →

Daten aus PubMed / NCBI. Den Volltext und die aktuellsten Informationen finden Sie stets im offiziellen Eintrag.

↑