Germantown, Maryland-based Senseonics received FDA clearance for Eversense 365 in September 2024. It launched the year-long CGM implant with its global distribution partner, Ascensia Diabetes Care, the following month. It has since taken over full commercial activity for the technology.
Now, the company can bring the system to Europe, earning CE mark in compliance with the EU Medical Device Regulation (MDR). This comes on the heels of the launch of Eversense 365 with Sequel Med Tech’s twiist pump, marking the first pump integration for the CGM.
With CE mark in hand, Senseonics plans to launch Eversense 365 in Germany, Italy, Spain and Sweden in the coming months.
Meanwhile, Senseonics continues to work toward an FDA investigational device exemption (IDE) submission for its next-generation Gemini transmitter-less CGM by the end of this year.
“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 (AID) System in the U.S., and simultaneously await planned completion of the Gemini trial in the second half of the year.”
Read more about Senseonics and the rest of the diabetes tech industry in our free Diabetes Technology Special Report.
(Learn more about Senseonics and the CGM market in our in-depth MedTech Market Report on CGMs, available to purchase at MassDevice)
Eversense 365 is the world’s first 365-day CGM system. It also holds clearance as an integrated CGM (iCGM) system, meaning it can work with compatible medical devices. Those include insulin pumps as part of automated insulin delivery systems, like twiist.
Market-leading, non-implanted CGMs like Abbott’s and Dexcom’s have wear times around two weeks. For Eversense 365 users, this means no frequent sensor changes and only one insertion and one “Day 1” every year.
The company says its sensor survivability across 12 months reduces the burden of data interruptions from frequent short-term CGM failures or changes. The sensor rests under the skin, meaning it can not be knocked off, minimizing inconveniences and replacement costs. In terms of comfort, users can change its gentle, silicone-based adhesive daily with almost no skin reactions.
Eversense 365 delivers consistent accuracy across one year, with almost zero false alerts from compression lows during the night. It offers the freedom to remove the transmitter device without wasting a sensor or adding a warm-up period. Eversense 365 also has on-body vibration alerts for improved discretion, alerting patients even when their mobile phone is out of sight.
