All apps · Heart & circulation

Is eMurmur Heart AI FDA approved or cleared?

Yes. eMurmur Heart AI by CSD Labs GmbH is named in the FDA register with a 510(k) clearance, first authorised in 2022, latest decision in 2025.

At a glance

Product	eMurmur Heart AI
Maker	CSD Labs GmbH
Care area	Heart & circulation
What it does	AI software that analyses heart sounds from digital stethoscopes to detect murmurs
FDA	510(k), latest decision 2025
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	emurmur.com
Status	FDA verified
Last checked	18 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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