All apps · Diabetes & metabolism

Is Insulia FDA approved or cleared?

Yes. Insulia by Voluntis SA is named in the FDA register with a 510(k) clearance, first authorised in 2016, 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	Insulia
Maker	Voluntis SA
Care area	Diabetes & metabolism
What it does	Digital insulin management platform with AI-powered dosing recommendations
FDA	510(k), latest decision 2023
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	insulia.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.

Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes

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