PubMed

Is the FDA regulation of cardiology AI devices supporting cardiovascular innovation: a scoping review.

PMID: 40835433 · 2026-02-23

A, h, m, e, d, , H, u, s, s, a, i, n, ;, , A, h, m, a, d, , G, u, n, i, ;, , R, i, s, h, i, k, e, s, h, , G, a, n, d, h, e, w, a, r, ;, , J, o, h, n, , W, a, r, n, e, r, -, L, e, v, y, ;, , A, l, e, x, a, n, d, e, r, , D, a, v, i, d, s, o, n, ;, , K, a, m, a, l, , S, h, a, h, ;, , A, r, a, , D, a, r, z, i, ;, , H, u, t, a, n, , A, s, h, r, a, f, i, a, n

ZeitschriftHeart (British Cardiac Society)

Jahr2026-02-23

PMID40835433

Zusammenfassung

Artificial intelligence (AI) and machine learning (ML) have shown immense potential in cardiology, leveraging data-driven insights to enhance diagnosis, treatment planning and patient care. This study presents a comprehensive evaluation of US Food and Drug Administration (FDA)-approved AI/ML devices in cardiology, analysing trends in clinical applications, regulatory pathways and evidence transparency. FDA clearance summaries from the AI/ML medical device database were reviewed to identify cardi

Offizielle Quelle

Auf PubMed ansehen →

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