US-based medical technology company Senseonics has secured the CE mark approval for its Eversense continuous glucose monitoring (CGM) system.
The system is composed of features including an implanted glucose sensor that lasts up to 90 days; a wearable and removable smart transmitter to calculate glucose levels, and a mobile application to display real-time glucose readings.
Senseonics president and CEO Dr Tim Goodnow said: "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."
Enveloped in a biocompatible material, the Eversense sensor uses a fluorescent, glucose indicating polymer and is implanted subcutaneously in the upper arm.
The smart transmitter is worn on the upper arm and is intended to wirelessly power the normally dormant sensor to activate the glucose measurement process.
The transmitter receives the necessary data from the sensor and calculates the glucose concentration.
The mobile application receives and displays the sensor glucose data from the Eversense Smart Transmitter.
It is aimed at providing easy access to real-time glucose measurements without requiring another dedicated device to carry.
Claimed to be the world’s first long-term wear sensor, the system eliminates the requirement of sensor insertion done on a weekly basis.
The system is designed for a continuous measuring of interstitial fluid glucose levels in adults and to be used as an adjunctive device; to complement information obtained from standard home blood glucose meters.
A multicentre European PRECISE pivotal trial, conducted earlier, has exhibited accuracy and safety results after using the Eversense CGM System for 90 days.
Senseonics plans to undertake market surveillance activities on the Eversense CGM System which will include gathering long-term safety and performance data from repeated sensor insertions.