All apps · Sleep & breathing

App icon of AeviceMD, from the App Store

Is AeviceMD FDA approved or cleared?

Yes. AeviceMD by Aevice Health Pte. Ltd. is named in the FDA register with a 510(k) clearance, first authorised in 2023, latest decision in 2025.

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

At a glance

Product	AeviceMD
Maker	Aevice Health Pte. Ltd.
Care area	Sleep & breathing
What it does	AI-powered stethoscope for lung and heart sound analysis with telemedicine integration
FDA	510(k), latest decision 2025
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	aevicemd.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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