Is SmartSpectra Vital Signs Monitor FDA approved or cleared?
Yes. SmartSpectra Vital Signs Monitor by Presage Technologies is named in the FDA register with a 510(k) clearance, 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 | SmartSpectra Vital Signs Monitor |
|---|---|
| Maker | Presage Technologies |
| Care area | Vital signs & remote monitoring |
| What it does | Camera-based software that measures pulse and breathing rate from video |
| 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 | presagetech.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