Senseonics’ Eversense 365 CGM Earns EU Approval

Senseonics announced that it has received CE mark approval for its Eversense 365 continuous glucose monitoring (CGM) system.

According to the company, Eversense 365 is the first and only one-year CGM. It was approved by the U.S. Food and Drug Administration (FDA) in September 2024 and launched across the country a month later.

The company plans to launch Eversense 365 in Germany, Italy, Spain, and Sweden in the coming months.

Since it’s the only CGM with a 365-day sensor, it means no frequent sensor changes and one insertions and one “Day 1” every year. The tiny sensor rests under the skin so it can’t be knocked off, and a silicone-based adhesive can be changed daily and causes almost no skin reactions.

The CGM features a removable transmitter that can be taken on and off without wasting a sensor or adding a warm-up period. On-body vibration alerts keep patients notified even when their mobile phone is out of sight.

“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, Ph.D., 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 (AID) System in the U.S., and simultaneously await planned completion of the Gemini trial in the second half of the year.”

It was cleared as an integrated CGM (iCGM), meaning it can integrate with compatible medical devices including insulin pumps as part of an automated insulin delivery (AID) system.