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Is CapsoCam Plus FDA approved or cleared?

Yes. CapsoCam Plus by CapsoVision, Inc. is named in the FDA register with a 510(k) clearance, first authorised in 2016, latest decision in 2024.

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

At a glance

Product	CapsoCam Plus
Maker	CapsoVision, Inc.
Care area	Imaging & AI diagnostics
What it does	Capsule endoscopy system for gastrointestinal imaging and diagnosis
FDA	510(k), latest decision 2024
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	capsovision.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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