App icon of Vibrant Gastro, from the App Store

Is Vibrant Gastro FDA approved or cleared?

Yes. Vibrant Gastro by Vibrant Ltd. is named in the FDA register with a De Novo authorisation, first authorised in 2022, latest decision in 2023.

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

At a glance

Product	Vibrant Gastro
Maker	Vibrant Ltd.
Care area	Other
What it does	Vibrating capsule taken by mouth to treat chronic constipation
FDA	De Novo, latest decision 2023
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	vibrantgastro.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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