Is Instinct Sensor (Guardian connect) FDA approved or cleared?
Partly. Instinct Sensor (Guardian connect) belongs to a product family by Medtronic Diabetes that holds a PMA approval, latest decision in 2018, 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 | Instinct Sensor (Guardian connect) |
|---|---|
| Maker | Medtronic Diabetes |
| Care area | Diabetes & metabolism |
| What it does | Continuous glucose monitoring system with predictive low glucose alerts |
| FDA | PMA, latest decision 2018 (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 | medtronicdiabetes.com |
| Status | FDA verified |
| Last checked | 17 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
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