Senseonics to enter EU markets with Eversense 365 CGM system
By HME News Staff
Updated 8:49 AM CST, Mon February 2, 2026
GERMANTOWN, Md. - Senseonics Holdings has announced CE Mark approval for the Eversense 365 CGM system, paying the way for the company to enter the German, Italian, Spanish and Swedish markets 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,” said Tim Goodnow, PhD, president and CEO of Senseonics. “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. 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.” The Eversense 365, billed as the world’s first and only one-year CGM, was approved by the U.S. Food and Drug Administration (FDA) in September of 2024 and launched in the country one month later.
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