Senseonics Holdings (NYSE:SENS) and closely-held Ascensia Diabetes Care herald a significant breakthrough in diabetes technology and management, announcing FDA approval of Eversense 365, the world’s first one-year continuous glucose monitoring (CGM) system with a 365-day sensor for adults aged 18 and over with Type 1 and Type 2 diabetes.
The FDA has cleared Eversense 365 as an integrated CGM (iCGM), meaning it can integrate with compatible medical devices, including insulin pumps for automated insulin delivery (AID) systems. It is designed to addresses common limitations associated with AID systems. Ascensia expects to initiate the U.S. launch of Eversense 365 in the fourth quarter of 2024.
Unlike short-term CGMs, which require sensor changes every 10-14 days, the fully-implantable Eversense 365 features a 365-day sensor that aims to reduce data interruptions caused by frequent sensor changes or failures. It also minimizes false alerts from compression lows during sleep. The discreet, silicon-based, under-the-skin sensor is less prone to dislodgement, reducing wasted sensors and replacement costs. The system includes a removable transmitter that can be taken on and off without requiring a warm up period or wasting a sensor. It also provides on-body vibration alerts to keep users informed, even when their mobile devices are out of sight.
In a statement, Tim Goodnow, Ph.D., president and CEO of Senseonics, said, “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.”
Brian Hansen, president of CGM at Ascensia, said, “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.”
