All apps · Sleep & breathing

Is Inspire FDA approved or cleared?

Not as such. Inspire Medical Systems holds a PMA approval for related hardware, latest decision in 2026, but Inspire itself is not named in the FDA record.

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

At a glance

Product	Inspire
Maker	Inspire Medical Systems
Care area	Sleep & breathing
What it does	Sleep apnea therapy monitoring app for Inspire implant patients
FDA	PMA, latest decision 2026
Verification level	Related hardware authorised; this app itself is not named (checked 18 October 2026)
EU (CE)	No CE listing found
Website	inspiresleep.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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