All apps · Diabetes & metabolism

App icon of twiist AID System, from the App Store

Is twiist AID System FDA approved or cleared?

Yes. twiist AID System by DEKA Research & Development is named in the FDA register with a 510(k) clearance, first authorised in 2025, latest decision in 2026.

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

At a glance

Product	twiist AID System
Maker	DEKA Research & Development
Care area	Diabetes & metabolism
What it does	Automated insulin delivery system with app control
FDA	510(k), latest decision 2026
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	twiist.com
Status	FDA verified
Last checked	7 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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