Senseonics announces CE Mark approval for Eversense 365 CGM system

Senseonics (SENS) announced CE Mark approval for the Eversense 365 CGM system. “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, president and CEO 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 System in the U.S., and simultaneously await planned completion of the Gemini trial in the second half of the year.”