Is EyeBOX FDA approved or cleared?
Yes. EyeBOX by Oculogica, Inc. is named in the FDA register with a De Novo authorisation, first authorised in 2018, latest decision in 2026.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | EyeBOX |
|---|---|
| Maker | Oculogica, Inc. |
| Care area | Brain & nerves |
| What it does | Eye-tracking test that helps clinicians assess concussion |
| FDA | De Novo, latest decision 2026 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | oculogica.com |
| Status | FDA verified |
| Last checked | 6 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Other apps in Brain & nerves
- Brainomix 360
- BrainScope
- Cala Trio
- CANTAB Insight
- CT-132
- EmbracePlus
- Empatica Parkinson's Monitoring (PKG Monitor)
- Encora X1
All certified apps and devices for brain and nerve conditions