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Is Brainomix 360 FDA approved or cleared?

Yes. Brainomix 360 by Brainomix Limited is named in the FDA register with a 510(k) clearance, first authorised in 2020, latest decision in 2026.

In the EU: CE class IIb, found in EUDAMED. The manufacturer holds a valid notified body certificate under the MDR in EUDAMED.

At a glance

Product	Brainomix 360
Maker	Brainomix Limited
Care area	Brain & nerves
What it does	AI-powered stroke imaging analysis platform for emergency care
FDA	510(k), latest decision 2026
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	Class IIb
EU certificate	Manufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026)
Website	brainomix.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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