Eversense Continuous Glucose Monitoring (CGM) System receives CE Mark.-Senseonics Holdings, Inc.

Senseonics Holdings, Inc. a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, announced it has received CE Mark approval for the Eversense Continuous Glucose Monitoring (CGM) System.The Eversense System includes an implanted glucose sensor that lasts up to 90 days, a wearable and removable smart transmitter to calculate glucose levels, and a mobile app for display of real-time glucose readings. The Eversense System is now the world�s first long-term wear sensor, which eliminates the weekly sensor insertion required by currently marketed CGM systems.

The system is indicated for continually measuring interstitial fluid glucose levels in adults and to be used as an adjunctive device; to complement information obtained from standard home blood glucose meters. In conjunction with the CE Mark approval, Senseonics will conduct post market surveillance activities which will include gathering long-term safety and performance data from repeated sensor insertions.

Comment: The previously presented multi-center European PRECISE pivotal trial showed strong accuracy and safety results throughout the 90 day use of the Eversense CGM System.