Senseonics Files for CE Mark Approval of Eversense 365 CGM System

Senseonics Holdings, Inc. (NYSE American: SENS), a leader in long-term continuous glucose monitoring (CGM) technology, has officially submitted its Eversense® 365 CGM system for CE Mark approval under the EU Medical Device Regulation (MDR). If approved, the system will become available in key European markets through Senseonics’ commercial partner, Ascensia Diabetes Care.

Eversense 365, the first and only one-year CGM, received FDA approval in September 2024 and launched in the U.S. the following month. The device provides a differentiated CGM experience, addressing key limitations of short-term CGMs with its long-lasting sensor, removable smart transmitter, and exceptional accuracy over a full year.

Tim Goodnow, PhD, President & CEO of Senseonics, highlighted the significance of this milestone, stating, “CE Mark submission for Eversense 365 brings us closer to improving diabetes management for patients in Europe. Given the strong response to our U.S. launch, we are eager to introduce this once-a-year CGM solution to millions in the EU.”

Brian Hansen, President of CGM at Ascensia Diabetes Care, emphasized the system’s impact: “The feedback from endocrinologists, general practitioners, and diabetes patients has been overwhelmingly positive. We look forward to replicating this success in Europe.”

Eversense 365 has been cleared in the U.S. as an integrated CGM (iCGM), enabling compatibility with insulin pumps and automated insulin delivery (AID) systems. Senseonics is actively engaging with pump manufacturers to expand integration opportunities, further enhancing diabetes management for patients worldwide.