{"id":"7478da863b08","type":"article","url":"https://hartvaat.nl/2026/02/23/regulering-van-ai-in-de-cardiologie-door-de-fda-een-scoping-review/","title":"Regulering van AI in de cardiologie door de FDA: een scoping review","title_en":"Is the FDA regulation of cardiology AI devices supporting cardiovascular innovation: a scoping review","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Heart","doi":"http://heart.bmj.com/cgi/content/short/112/6/300?rss=1","source_url":"https://doi.org/http://heart.bmj.com/cgi/content/short/112/6/300?rss=1","authors":["Hussain","A.","Guni","A.","Gandhewar","R.","Warner-Levy","J.","Davidson","A.","Shah","K.","Darzi","A.","Ashrafian","H."],"significance":6,"published":"2026-02-23","source_date":"2026-02-23","image":"https://hartvaat.nl/global/img/e8315535d29a.webp","kennis":["https://hartvaat.nl/kennis/diagnostiek/cardiale-mri/"],"congress":"","summary_en":"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.","created":"2026-07-03T10:25:06Z","updated":"2026-07-03T13:24:34Z","licence":"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.","body_markdown":"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.","abstract_original":"Background\n

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.

\n\nMethods\n

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.

\n\nResults\n

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."}