Senseonics Wins FDA Clearance for Year-Long CGM

Senseonics has received FDA clearance for a 365-day continuous glucose monitor (CGM).

The Germantown, MD-based company said Eversense 365 is the first year-long CGM system, designed to minimize the frequency of sensor replacements and provide consistent, long-term glucose monitoring.

Senseonics has a previous device version that lasts up to 180 days.

“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, PhD, 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.”

Senseonics is working with its partner Ascensia Diabetes Care to distribute Eversense 365. The product is set to launch in 4Q24.

Marie Thibault, an analyst with BTIG, went in depth about the indications for Eversense 365, in a research note.

“The 365-day system is indicated for adults with Type 1 and Type 2 diabetes and has an iCGM designation similar to its predicate, the 180-day Eversense CGM,” Thibault wrote in a research note. “The iCGM designation allows for Eversense systems to be part of an automated insulin delivery (AID) system. Sensonics continues to engage in active discussions with pump manufacturers for a potential interoperable AID system with Eversense in the future.”

Related:Senseonics Eyes Longer-Term CGM Sensor

Red hot activity in the CGM space

The CGM side of the diabetes tech market has been buzzing with activity these past few months.

In early August, Abbott Laboratories and Medtronic kicked things off with the announcement of a collaboration. The pact would have Abbott developing a continuous glucose monitor that Medtronic would market.

A few weeks after Abbott and Medtronic’s landmark announcement, Dexcom launched Stelo, the first over-the-counter CGM. The San Diego, CA-based company had won a nod from FDA for Stelo in March.

Abbott would soon follow suit and said it was launching Lingo, its OTC CGM. The system was cleared in June.