All apps · Heart & circulation

Is CaRi-Heart FDA approved or cleared?

Yes. CaRi-Heart by Caristo Diagnostics Ltd. is named in the FDA register with a De Novo authorisation, latest decision in 2026.

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

At a glance

Product	CaRi-Heart
Maker	Caristo Diagnostics Ltd.
Care area	Heart & circulation
What it does	AI cardiac risk prediction platform using coronary CT imaging analysis
FDA	De Novo, latest decision 2026
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	caristo.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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