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Is SAINT® Neuromodulation System FDA approved or cleared?

Yes. SAINT® Neuromodulation System by Magnus Medical, Inc. is named in the FDA register with a 510(k) clearance, latest decision in 2022.

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

At a glance

Product	SAINT® Neuromodulation System
Maker	Magnus Medical, Inc.
Care area	Mental health
What it does	Precision neuromodulation system for treatment-resistant depression
FDA	510(k), latest decision 2022
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	magnusmedical.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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