Is Carnation Ambulatory Monitor FDA approved or cleared?
Yes. Carnation Ambulatory Monitor by Bardy Diagnostics (Baxter) is named in the FDA register with a 510(k) clearance, first authorised in 2014, latest decision in 2023.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Carnation Ambulatory Monitor |
|---|---|
| Maker | Bardy Diagnostics (Baxter) |
| Care area | Heart & circulation |
| What it does | Long-term ambulatory ECG monitoring system for cardiac rhythm assessment |
| FDA | 510(k), latest decision 2023 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | bardydx.com/solutions/cam |
| 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 Heart & circulation
- AccurECG
- Apple Watch Hypertension Notifications
- Apple Watch/ECG
- Biocare 12-Lead ECG Machine
- BPM Pro 2
- CADScor®System
- Cardiacsense
- CardioFlux