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Is ForeseeHome FDA approved or cleared?

Yes. ForeseeHome by Notal Vision is named in the FDA register with a De Novo authorisation, first authorised in 2009, 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	ForeseeHome
Maker	Notal Vision
Care area	Eyes & vision
What it does	At-home monitoring device for age-related macular degeneration detection
FDA	De Novo, latest decision 2024
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	notalvision.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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