All apps · Diabetes & metabolism

Is MODI System FDA approved or cleared?

Yes. MODI System by DreaMed Diabetes, Ltd. is named in the FDA register with a 510(k) clearance, latest decision in 2026.

At a glance

Product	MODI System
Maker	DreaMed Diabetes, Ltd.
Care area	Diabetes & metabolism
What it does	Software that uses CGM data to recommend insulin doses for adults with type 2 diabetes on insulin injections
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	dreamed.ai
Status	FDA verified
Last checked	18 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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