Senseonics, Ascensia launch one-year CGM system 

GERMANTOWN, Md., and PARSIPPANY, N.J. – Senseonics and Ascensia Diabetes Care have announced that the U.S. Food and Drug Administration has cleared the next-generation Eversense 365 CGM, the first one-year CGM system. “The approval of Eversense 365 represents a significant leap in CGM innovation,” said Tim Goodnow, PhD, president and CEO of Senseonics. “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. 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.” The Eversense 365 CGM has been approved by the FDA for Type 1 and Type 2 diabetes for people aged 18 years and older. It has been approved as an integrated CGM system, meaning it can integrate with compatible medical devices, including insulin pumps, as part of an automated insulin delivery system. The companies say a one-year system has numerous benefits, including no frequent sensor changes, and only one insertion and one “Day 1” every year, compared to every 10 to 14 days with a short-term system. Ascensia expects to initiate the launch of Eversense 365 in the U.S. in the fourth quarter of 2024, with work ongoing to transition coverage availability to facilitate immediate access to as many users as possible.