All apps · Vital signs & remote monitoring

Is Biobeat FDA approved or cleared?

Yes. Biobeat by Biobeat Technologies Ltd. is named in the FDA register with a 510(k) clearance, first authorised in 2019, latest decision in 2025.

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

At a glance

Product	Biobeat
Maker	Biobeat Technologies Ltd.
Care area	Vital signs & remote monitoring
What it does	Continuous vital signs monitoring platform using wearable patch technology
FDA	510(k), latest decision 2025
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	biobeat.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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