All apps · Heart & circulation

Is CorVista FDA approved or cleared?

Yes. CorVista by CorVista Health / Analytics For Life is named in the FDA register with a 510(k) clearance, first authorised in 2023, 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	CorVista
Maker	CorVista Health / Analytics For Life
Care area	Heart & circulation
What it does	Point-of-care test that analyses resting heart and blood flow signals to help detect coronary artery disease
FDA	510(k), latest decision 2026
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	corvista.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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