Senseonics files for CE Mark
By HME News Staff
Updated 9:24 AM CST, Thu February 13, 2025
GERMANTOWN, Md. – Senseonics Holdings has filed for CE Mark registration for the Eversense 365 CGM system, paving the way for commercialization in European Union countries by Acensia Diabetes Care. “Completing the CE Mark submission for Eversense 365 brings us a step closer to improving lives and health outcomes for patients in Europe,” said Tim Goodnow, president and CEO of Senseonics. “Given the success we have had to date with the U.S. launch, we look forward to the opportunity to offer a ‘once a year solution’ for glucose control to the millions of people living with diabetes in the European union.” Acensia will distribute the Eversense 365 in German, Italy, Spain (including Andorra), Poland, Switzerland and Sweden. It launched in the U.S. in 2024.
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