Is Anura FDA approved or cleared?
Partly. Anura belongs to a product family by NuraLogix Corporation that holds a 510(k) clearance, latest decision in 2026, but this exact variant or app is not named in the FDA record.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Anura |
|---|---|
| Maker | NuraLogix Corporation |
| Care area | Vital signs & remote monitoring |
| What it does | Smartphone camera app that measures pulse rate and breathing rate from a short face video; other health and wellness scores in the app are not FDA cleared |
| FDA | 510(k), latest decision 2026 (product family) |
| Verification level | Product family authorised; this exact variant or app is not named (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | nuralogix.ai |
| 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 Vital signs & remote monitoring
- ActiGraph LEAP™
- AirStrip ONE
- Avidhrt Sense SpO2
- BabySat®
- Biobeat
- BioButton
- BioStamp nPoint
- BioVitalsHF & Biofourmis Platform