Senseonics obtains FDA clearance for one-year CGM

Senseonics, in collaboration with Ascensia Diabetes Care, has received FDA clearance for the Eversense 365, the first implantable glucose sensor designed for one-year wear, which doubles the duration of its previous sensor. This continuous glucose monitor (CGM) is implanted just beneath the skin, with a removable transmitter adhered to the surface, making it suitable for adults with Type 1 or Type 2 diabetes.

The Eversense 365 features an integrated CGM designation, allowing it to work as part of an automated insulin delivery system in coordination with insulin pumps. The company is currently in discussions with pump manufacturers regarding partnerships.

In addition to its extended wear time, the new sensor requires less frequent calibration—only once a week after the first two weeks—compared to the current model, which needs calibration twice daily initially. Senseonics aims for the new sensor to significantly increase its sales and user base by 2025.