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Is mdprostate FDA approved or cleared?

Yes. mdprostate by mediaire GmbH is named in the FDA register with a 510(k) clearance, latest decision in 2026.

In the EU: CE class IIb, found in EUDAMED. No notified body certificate is visible in EUDAMED yet; ask the maker for it (devices still under the older MDD rules often have none listed).

At a glance

Product	mdprostate
Maker	mediaire GmbH
Care area	Imaging & AI diagnostics
What it does	AI software for prostate MRI analysis
FDA	510(k), latest decision 2026
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	Class IIb
EU certificate	Not visible in EUDAMED yet (checked 18 October 2026)
Website	mediaire.de
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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