Is Kneu Platform (formerly Neu Platform) FDA approved or cleared?
Yes. Kneu Platform (formerly Neu Platform) by Kneu Health Digital Ltd. (formerly Neu Health Digital) is named in the FDA register with a 510(k) clearance, first authorised in 2025, 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 | Kneu Platform (formerly Neu Platform) |
|---|---|
| Maker | Kneu Health Digital Ltd. (formerly Neu Health Digital) |
| Care area | Brain & nerves |
| What it does | Smartphone platform that measures Parkinson's disease movement symptoms remotely |
| FDA | 510(k), latest decision 2026 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | kneu.com |
| Status | FDA verified |
| Last checked | 7 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