18 Sep 2024

FDA Approves Eversense 365 CGM System for Diabetes Management

Senseonics Holdings, Inc. and Ascensia Diabetes Care announced the FDA approval of Eversense® 365, the first implantable continuous glucose monitoring (CGM) system with a 365-day sensor. The system provides reliable glucose data for an entire year with only one sensor insertion and “Day 1” calibration, significantly reducing sensor replacements compared to existing CGMs.


Eversense 365 offers several advantages, including fewer data interruptions, high sensor survivability, and customizable on-body vibration alerts for better user experience. The implantable design also prevents accidental detachment, reducing the need for sensor replacements and false alerts during sleep.


Set for a Q4 2024 U.S. launch, Ascensia is working to expand coverage for immediate access. The system’s iCGM clearance allows integration with insulin pumps in automated insulin delivery systems, providing greater flexibility and accuracy for diabetes management.


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