# Regulering van AI in de cardiologie door de FDA: een scoping review *geplaatst 2026-02-23 · Algemeen · Heart · doi http://heart.bmj.com/cgi/content/short/112/6/300?rss=1 · https://hartvaat.nl/2026/02/23/regulering-van-ai-in-de-cardiologie-door-de-fda-een-scoping-review/* Een scoping review van FDA-goedgekeurde AI/ML-devices in de cardiologie analyseert trends in klinische toepassingen, regelgevingstrajecten en transparantie van bewijs. De auteurs bespreken of de huidige regulering cardiovasculaire innovatie voldoende ondersteunt. ## English: Is the FDA regulation of cardiology AI devices supporting cardiovascular innovation: a scoping review This scoping review of FDA-approved AI/ML devices in cardiology analyzed trends in clinical applications and regulatory pathways, assessing whether the approval framework adequately supports cardiovascular innovation. ## Abstract (original, from the publication) Background

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.

 Methods

FDA clearance summaries from the AI/ML medical device database were reviewed to identify cardiology-specific applications. Devices were categorised using the descriptive, diagnostic, predictive and prescriptive framework. Regulatory pathways, AI technologies and validation data were critically assessed.

 Results

Of 1016 FDA-approved AI/ML devices, 277 (27.3%) had cardiology applications, predominantly for imaging (65.3%) and diagnostics (64.3%). Predictive and prescriptive tools constituted only 5. Auteurs: Hussain, A., Guni, A., Gandhewar, R., Warner-Levy, J., Davidson, A., Shah, K., Darzi, A., Ashrafian, H. --- Bron: Heart, https://doi.org/http://heart.bmj.com/cgi/content/short/112/6/300?rss=1. Bijgewerkt 2026-07-03T13:24:34Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.