Senseonics’ Eversense CGM System receives CE Mark approval

Senseonics - Eversense CGM System

Senseonics announced that its Eversense Continuous Glucose Monitoring (CGM) System has received CE Mark and is thus “legally prepared” to be sold in Europe.

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.

“The CE Mark approval is a significant accomplishment for Senseonics as this application required rigorous regulatory review against high clinical and safety standards,” Dr. Tim Goodnow, CEO and President of Senseonics, said in a statement. “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 system 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.

Senseonics will start conducting 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,” added Dr. Goodnow.