All apps · Heart & circulation

Is EchoGo Heart Failure FDA approved or cleared?

Yes. EchoGo Heart Failure by Ultromics Ltd. is named in the FDA register with a 510(k) clearance, first authorised in 2022, latest decision in 2024.

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

At a glance

Product	EchoGo Heart Failure
Maker	Ultromics Ltd.
Care area	Heart & circulation
What it does	AI-powered echocardiogram analysis for heart failure detection and assessment
FDA	510(k), latest decision 2024
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	ultromics.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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