Is Vital Sync Virtual Patient Monitoring Platform FDA approved or cleared?
Yes. Vital Sync Virtual Patient Monitoring Platform by Covidien (Medtronic) is named in the FDA register with a 510(k) clearance, first authorised in 2013, latest decision in 2016.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Vital Sync Virtual Patient Monitoring Platform |
|---|---|
| Maker | Covidien (Medtronic) |
| Care area | Vital signs & remote monitoring |
| What it does | Advanced remote patient monitoring platform with AI-powered analytics |
| FDA | 510(k), latest decision 2016 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | medtronic.com/covidien/en-gb/products/health-informatics-and-monitoring/vital-sync-virtual-patient-monitoring-platform-2-6.html# |
| 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