FDA OKs Senseonics’ Eversense 365-Day Implantable CGM

Senseonics and Ascensia Diabetes Care announced that the U.S. Food and Drug Administration (FDA) has cleared the next-gen Eversense 365 continuous glucose monitoring (CGM) system for adult Type 1 and Type 2 diabetes patients.
 
Eversense 365 was cleared as an integrated CGM (iCGM) system, which means it can integrate with compatible medical devices like insulin pumps as part of an automated insulin delivery (AID) system.
 
The device is currently the only CGM with a 365-day sensor—there’s only one insertion and one “Day 1” every year, the company said. The tiny sensor rests under the skin so it can’t be knocked off, minimizing the inconvenience and cost of regular replacements.
 
Eversense 365 is also the only CGM with a removable transmitter that can be taken on and off without wasting a sensor or adding a warm-up period. On-body vibration alerts notify patients even when their mobile phone is out of their sight.
 
“The approval of Eversense 365 represents a significant leap in CGM innovation. Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes,” said Tim Goodnow, Ph.D., president and CEO of Senseonics. “Eversense 365 was ‘designed for real life’ and is optimally suited to help people with diabetes increase time in range of desired glucose levels and lower A1c. The delivery of the world’s first 365 day sensor is a seminal event for Senseonics and we’re excited to bring it to people with diabetes.”
 
Ascensia expects to begin the U.S. launch of Eversense 365 in Q4 2024.
 
“Managing diabetes can be stressful and it is important for technology to disrupt life as little as possible to limit this burden,” said Brian Hansen, president of CGM at Ascensia Diabetes Care. “Eversense 365 allows people with diabetes to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs. We are very excited about Senseonics’ ability to once again bring true innovation to the CGM space and are working closely with our partner to make Eversense 365 commercially available as soon as possible. In parallel, our partnership discussions with various pump manufacturers continue to progress, as we look to leverage Eversense 365’s unique potential to simplify life with integrated automated insulin delivery (AID) systems.”