All apps · Heart & circulation

Is CADScor®System FDA approved or cleared?

Yes. CADScor®System by Acarix A/S is named in the FDA register with a De Novo authorisation, latest decision in 2020.

In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.

At a glance

Product	CADScor®System
Maker	Acarix A/S
Care area	Heart & circulation
What it does	Non-invasive coronary artery disease detection system using acoustic analysis
FDA	De Novo, latest decision 2020
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	acarix.com
Status	FDA verified
Last checked	6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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