Eversense 365 CGM System
US$ 199 Price in USD — free shipping included
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Implantable continuous glucose monitor: a sensor placed under the skin by a clinician measures interstitial glucose for up to one year. A removable transmitter worn on the skin reads the sensor and sends data to a smartphone app. For adults 18+ with type 1 or type 2 diabetes.
Key facts
| Product | Eversense 365 Continuous Glucose Monitoring System |
|---|---|
| Manufacturer | Senseonics, Inc. (US commercialization by Senseonics since January 1, 2026; previously Ascensia Diabetes Care) |
| Intended users | Home / personal use |
| US FDA status | 510(k) cleared — K241335 |
| Market status | Available |
Main features
- Implanted sensor lasts up to 365 days
- Glucose readings sent to the app every 5 minutes, with trends and high/low alerts
- Fingerstick calibration about once a week after day 14
- Removable, reusable transmitter with on-body vibration alerts
- iCGM designation (compatible with automated insulin dosing systems)
- Sensor contains a steroid (dexamethasone acetate)
Connectivity
Smart transmitter to the Eversense smartphone app (data every 5 minutes).
AI and analysis software
The manufacturer does not describe built-in AI for this device. Because its data can leave the device, it can in principle feed separate analysis software; any such software is a distinct product with its own regulatory status.
Regulatory status in the United States
FDA 510(k) clearance: K241335. Eversense 365 iCGM, cleared September 16, 2024. Earlier Eversense/E3 systems were PMA approved (P160048).
Related guide: Cloud-Based Medical Devices.
Sources
Profile verified against public sources in October 2026. Trademarks belong to their owners.
