Senseonics Holdings, a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, announced CE Mark approval for the Eversense 365 CGM system.

Eversense 365 is the world’s first and only one-year CGM, which was approved by the United States (US) Food and Drug Administration in September of 2024 and launched across the country in October of the same year.

The Eversense 365 CE Mark submission was prepared in compliance with the EU Medical Device Regulation (MDR) and is now approved for commercialisation in the European Union (EU). The Company expects to launch Eversense 365 in Germany, Italy, Spain and Sweden in the coming months.

“European approval for Eversense 365 represents the latest achievement in our long-term growth strategy for Senseonics and expands our total addressable market by over 30 million patients living with diabetes in the EU. As we take full ownership of all commercial activities for Eversense 365, we expect our expansion in Europe to contribute to top-line revenue growth, while offering a single year-long CGM solution to glucose monitoring,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “2026 will be an exciting year as we drive commercial progress in the U.S. and Europe, expect the impact of the integration with Sequel’s twiist Automated Insulin Delivery (AID) System in the U.S., and simultaneously await planned completion of the Gemini trial in the second half of the year.”