Senseonics’ CE Mark for Eversense continuous glucose monitoring system

Germantown, Maryland – 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, has received CE Mark approval for the Eversense Continuous Glucose Monitoring (CGM) System.

“The CE Mark approval is a significant accomplishment for Senseonics as this application required rigorous regulatory review against high clinical and safety standards,” said Dr. Tim Goodnow, CEO and president of Senseonics. “The approval enables the company to market and sell the Eversense System in European Union (EU) member countries, and we are prepared to make this important medical device available to people with diabetes.”

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

CE Mark confirms that the product meets the Essential Requirements of the Active Implantable Medical Device Directive (AIMDD 90/385/EEC). 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.

“We look forward to introducing the Eversense CGM System in Europe beginning with commercialization efforts in Sweden in partnership with our exclusive distributor, Rubin Medical,” Goodnow added.

Senseonics reported its First Quarter 2016 earnings after market close on May 12, 2016 and held its First Quarter 2016 Earnings Call on May 12, 2016, at 4:30 pm ET.

About Senseonics
Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Our first generation continuous glucose monitoring (CGM) system, Eversense, includes a small sensor, smart transmitter and mobile application. Based on fluorescence sensing technology, the sensor is designed to be inserted subcutaneously and communicate with the smart transmitter to wirelessly transmit glucose levels to a mobile device. After insertion, the sensor is designed to continually and accurately measure glucose levels.

Source: Senseonics