Senseonics has filed to obtain CE Mark registration for its one-year continuous glucose monitoring (CGM) system, Eversense 365.

The CE Mark submission aligns with the EU Medical Device Regulation (MDR), and upon approval, will enable commercialisation in European Union (EU) member countries through the company’s partner, Ascensia Diabetes Care.

Following approval, plans are in place to distribute the system in Italy, Germany, Poland, Sweden, Spain, and Switzerland.

Senseonics president and CEO Tim Goodnow said: “Completing the CE Mark submission for Eversense 365 brings us a step closer to improving lives and health outcomes for patients in Europe.

“Given the success we have had to date with the US launch of Eversense 365 by our partner, Ascensia, we look forward to the opportunity to offer a ‘once-a-year’ solution for glucose control to the millions of people living with diabetes in the EU.”

The system claims to offer a CGM experience with several advancements over traditional short-term CGMs, which typically last 10-14 days.

It features a small under-skin sensor, a removable smart transmitter that does not waste a CGM upon removal, and almost no false alerts from compression lows during sleep.

Requiring one calibration a week, the system offers consistent accuracy throughout the year.

In the US, Eversense 365 is recognised as an integrated CGM (iCGM) system, capable of integrating with compatible medical devices, such as insulin pumps, for automated insulin delivery (AID) systems.

It claims to address common limitations of AID systems, and partnership discussions with various pump manufacturers are advancing.

The CGM received the US Food and Drug Administration (FDA) approval in September 2024 and was launched in the market a month later.

The Eversense CGM systems, which include the Eversense 365 and Eversense E3, are designed for diabetic adults and are indicated to replace fingerstick blood glucose measurements for treatment decisions related to diabetes.

In February 2022, the Eversense E3 was approved by the FDA for use up to six months.