Senseonics Completes CE Mark Submission for Eversense 365, World's Longest-lasting Continuous Glucose Monitor

Core Viewpoint - Senseonics Holdings, Inc. has filed for CE Mark registration for its Eversense® 365 continuous glucose monitoring (CGM) system, aiming to expand its market presence in the European Union after a successful launch in the United States [1][3][4]. Group 1: Product Overview - Eversense 365 is the world's first and only CGM system designed to last for one year, having received FDA approval in September 2024 and launched in the U.S. in October 2024 [2]. - The Eversense 365 system is an integrated CGM (iCGM) that can work with compatible medical devices, including insulin pumps, as part of an automated insulin delivery (AID) system [6]. Group 2: Market Expansion - The CE Mark submission is in compliance with EU Medical Device Regulation (MDR) and, upon approval, will allow commercialization in EU member countries through Ascensia Diabetes Care, Senseonics' commercial partner [3]. - The initial distribution plans for Eversense 365 in Europe include Germany, Italy, Spain, Poland, Switzerland, and Sweden [3]. Group 3: Impact and Feedback - Feedback from the U.S. launch has been positive, with significant encouragement from endocrinologists, general practitioners, and patients, indicating a tangible impact on the lives of many diabetes patients [5]. - The company aims to provide a 'once a year' solution for glucose control to millions of people living with diabetes in the EU [4]. Group 4: Product Features - Eversense 365 offers several advantages over traditional short-term CGMs, including a longer lifespan, reduced waste, trusted alerts with high accuracy, maximum comfort with gentle adhesives, and consistent reliability with only one calibration required per week [8].