Senseonics obtains FDA clearance to pair CGM implant with insulin pumps

Senseonics announced it obtained an integrated continuous glucose monitoring (iCGM) designation from the FDA via the de novo pathway, enabling integration of its implantable CGM with pumps for automated insulin delivery. Though Senseonics' sales are modest compared to Abbott and Dexcom, analysts believe the iCGM designation and planned one-year sensor could broaden its appeal.

Eversense, Senseonics' CGM device, replaces fingerstick blood glucose measurements and lasts up to 180 days but needs daily calibration after day 21. Unlike dominant CGM patches by Abbott and Dexcom, Eversense is implantable.

The iCGM status allows Eversense to integrate with insulin pumps. Senseonics plans discussions with pump manufacturers for integrations adjusting insulin delivery based on CGM data.

Senseonics aims for FDA approval of its 365-day sensor in Q4 and can pursue iCGM status via the 510(k) pathway. It envisions the longer-lasting implant as the foundation for Gemini and Freedom self-powered versions, with Gemini's human testing slated for late 2024.