What You Should Know:
– Senseonics Holdings, Inc. and Ascensia Diabetes Care announced that the FDA has cleared the Eversense® 365 CGM system.
– This marks a significant advancement in diabetes management, offering a fully-implantable, long-term continuous glucose monitoring (CGM) solution for individuals with Type 1 and Type 2 diabetes aged 18 and older.
Eversense 365: Uninterrupted Living with Diabetes
Eversense 365 is set to transform the lives of people with diabetes by providing a highly differentiated CGM experience compared to short-term systems. Here’s what sets it apart:
- Longest-Lasting CGM: With a 365-day sensor, Eversense 365 eliminates the need for frequent sensor changes, requiring only one insertion and “Day 1” calibration annually, unlike short-term CGMs that need replacement every 10-14 days.
- Most Dependable CGM: The impressive sensor survivability over 12 months reduces data interruptions caused by frequent sensor failures or changes common in short-term CGM systems.
- No More Wasted Sensors: The tiny, implantable sensor eliminates the risk of accidental detachment, minimizing the inconvenience and cost of replacements.
- Trustworthy Alerts: Eversense 365 delivers exceptional accuracy consistently for a full year and virtually eliminates false alerts from compression lows during sleep.
- Maximum Comfort: The gentle, silicone-based adhesive can be changed daily and is associated with minimal skin reactions.
- Enhanced Freedom: The removable transmitter offers unparalleled flexibility, allowing users to take it off without wasting a sensor or requiring a warm-up period.
- Improved Discretion: On-body vibration alerts ensure users stay informed, even when their phone is out of reach.
Launch and Integration
Ascensia plans to launch Eversense 365 in the US in the fourth quarter of 2024, actively working to expand coverage availability for immediate user access.
The system’s iCGM clearance allows integration with compatible medical devices, such as insulin pumps within automated insulin delivery (AID) systems. Eversense 365 is uniquely positioned to overcome common AID limitations, and the companies are actively pursuing partnerships with pump manufacturers.
For further information on Eversense 365 and its availability, visit www.eversensecgm.com. Healthcare professionals interested in prescribing the Eversense CGM System can register at https://www.ascensiadiabetes.com/eversense/become-a-provider/.