All apps · Diabetes & metabolism

Is DreaMed advisor pro FDA approved or cleared?

Yes. DreaMed advisor pro by DreaMed Diabetes Ltd. is named in the FDA register with a De Novo authorisation, first authorised in 2018, latest decision in 2021.

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

At a glance

Product	DreaMed advisor pro
Maker	DreaMed Diabetes Ltd.
Care area	Diabetes & metabolism
What it does	AI-based insulin pump settings optimization platform for healthcare providers
FDA	De Novo, latest decision 2021
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	dreamed.ai
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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