Senseonics’ Eversense 365 CGM Receives CE Mark for Europe

Senseonics has secured a CE mark for its one-year continuous glucose monitor (CGM), Eversense 365, enabling launches in Germany, Italy, Spain, and Sweden. The expansion adds over 30 million patients to the company’s addressable market.

Unlike Dexcom and Abbott devices, which are worn as patches for up to two weeks, Eversense 365 is an implantable CGM lasting a full year. Senseonics first received CE approval for an earlier version in 2017 and FDA clearance in 2018, and launched the one-year version in the U.S. after FDA approval in 2024.

Originally planning a European launch with Ascensia Diabetes Care, Senseonics ended the deal and will now handle its own sales infrastructure, delaying the European rollout to early 2026.

The company expects 2025 sales of $35.2 million (up 56% vs 2024) and forecasts $60 million in 2026, reflecting growth driven by Eversense 365 and Senseonics taking control of U.S. and European commercialization.

31-01-2026