Senseonics Seeks CE Mark for Revolutionary One-Year Implantable Glucose Monitor
核心洞察
Senseonics (搜索) has submitted CE mark application for Eversense 365, the world's first continuous glucose monitoring system that functions for an entire year, revolutionizing diabetes (搜索) management.
The implantable CGM system, already FDA-cleared, offers unique advantages including consistent accuracy, elimination of frequent sensor changes, and on-body vibration alerts for enhanced patient convenience.
If approved, Ascensia Diabetes Care (搜索) will distribute the Eversense 365 system across multiple European markets, including Germany, Italy, Spain, Poland, Switzerland, and Sweden.
Senseonics (搜索) Holdings has taken a significant step toward expanding its innovative diabetes (搜索) management technology to the European market by submitting a CE mark application for its groundbreaking Eversense 365 continuous glucose monitoring (CGM) system.
The Eversense 365 system represents a paradigm shift in CGM technology as the world's first and only sensor designed to function for an entire year. This marks a substantial advancement compared to current market-leading non-implanted CGMs, such as those from Abbott and Dexcom (搜索), which typically require replacement every two weeks.
Advanced Features and Patient Benefits
The long-term implantable sensor offers multiple advantages for diabetes (搜索) management. Users benefit from consistent accuracy throughout the year-long wear period and experience almost zero false alerts from compression lows during nighttime. The system's unique design allows users to remove the transmitter without compromising sensor function or requiring additional warm-up periods.
A key innovation is the system's silicone-based adhesive, which can be changed daily while minimizing skin reactions. The device also features on-body vibration alerts, ensuring patients receive notifications even when their mobile devices are not nearby.
Technical Capabilities and Integration
The Eversense 365 has received clearance as an integrated CGM (iCGM) system, enabling compatibility with various medical devices, including insulin pumps for automated insulin delivery systems. This integration capability positions the device as a versatile component in comprehensive diabetes (搜索) management solutions.
"Completing the CE Mark submission for Eversense 365 brings us a step closer to improving lives and health outcomes for patients in Europe," stated Tim Goodnow, President and CEO of Senseonics (搜索). "Given the success we have had to date with the US launch of Eversense 365 by our partner, Ascensia, we look forward to the opportunity to offer a 'once a year' solution for glucose control to the millions of people living with diabetes (搜索) in the European Union."
Market Distribution and Availability
The system has already received FDA clearance and launched in the United States on October 1st through Senseonics (搜索)' global distribution partner, Ascensia Diabetes Care (搜索). Upon receiving CE Mark approval, Ascensia will manage distribution across key European markets, including Germany, Italy, Spain (including Andorra), Poland, Switzerland, and Sweden.
The extended wear time significantly reduces the burden of frequent sensor changes and data interruptions commonly associated with short-term CGM systems. Additionally, the subcutaneous placement ensures the sensor cannot be accidentally dislodged, minimizing both inconvenience and replacement costs for users.