Senseonics, a medtech manufacturer developing long-term, implantable continuous glucose monitoring (CGM) systems, and Ascensia Diabetes Care today announced FDA approval for the Eversense 365 CGM system for people with Type 1 and Type 2 diabetes aged 18 years and older. The company said Eversense 365 is the world’s first One Year CGM system.

The extended life means fewer sensor changes, and only one insertion and one “Day 1” every year. Senseonics said other short-term CGM systems need to be changed every 10-14 days. The company also said that sensor survivability across 12 months reduces the burden of data interruptions from frequent short-term CGM sensor failures or change.

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Eversense includes a small sensor that rests under the skin, meaning that it cannot be knocked off, and a silicone-based adhesive that can be changed daily. The removable transmitter which can be taken on and off without wasting a sensor or adding a warm up period and on-body vibration alerts keep patients notified even when their mobile phone is out of sight.

Ascensia expects to initiate the U.S. launch of Eversense 365 US in the fourth quarter of 2024. Eversense 365 has been cleared as an integrated CGM (iCGM) system, indicating that it can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system.

“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, a subsidiary of PHC Holdings Corporation (TSE 6523). “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.”