Medical technology firm Senseonics Holdings has received CE mark approval for its Eversense continuous glucose monitoring (CGM) system.
The system features an implanted glucose sensor, wearable and removable smart transmitter to calculate glucose levels, as well as mobile app for display of real-time glucose readings.
The sensor, which is based on fluorescence sensing technology, will be inserted subcutaneously and communicate with the smart transmitter to wirelessly transmit glucose levels to a mobile device.
Senseonics said the Eversense system eliminates the weekly sensor insertion required by currently marketed CGM systems.
An European multi-center Precise pivotal trial demonstrated the accuracy and safety of the Eversense CGM system.
Senseonics CEO and president Dr Tim Goodnow said: "The CE Mark approval is a significant accomplishment for Senseonics as this application required rigorous regulatory review against high clinical and safety standards.
"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."
Senseonics is engaged in the design, development and commercialization of glucose monitoring products for the diabetes patients.