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Is Dreem Headband FDA approved or cleared?

Yes. Dreem Headband by Beacon Biosignals, Inc. is named in the FDA register with a 510(k) clearance, first authorised in 2023, latest decision in 2024.

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

At a glance

Product	Dreem Headband
Maker	Beacon Biosignals, Inc.
Care area	Sleep & breathing
What it does	EEG headband that records sleep at home for sleep studies
FDA	510(k), latest decision 2024
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	beacon.bio
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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