European Regulators Approve Senseonics Glucose Monitoring System

Senseonics Holdings Inc., a company developing and commercializing a long-term, implantable continuous glucose monitoring (CGM) system for diabetics, 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 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, according to the company. 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.
 
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,” added Goodnow.
 
Senseonics Holdings Inc. designs, develops, and commercializes glucose monitoring products for diabetics. The company is based in Germantown, Md.