Senseonics has obtained CE mark approval for its next-generation Eversense E3 continuous glucose monitoring (CGM) System, which can be used for up to six months.
The system is intended to continually measure glucose levels in people aged 18 years and above with diabetes.
A prescription device, the Eversense CGM System can replace fingerstick blood glucose (BG) measurements to provide information for diabetes treatment decisions.
A qualified and certified health care provider performs the sensor insertion and removal procedures.
Eversense E3 offers patients a fully implantable third-generation sensor that uses proprietary sacrificial boronic acid (SBA) technology to boost sensor longevity.
It has a sensor wear duration of six months, making the device the longest-lasting CGM sensor available.
It also has a removable smart transmitter, which offers on-body vibratory notifications and transmits data to a mobile application that displays glucose values, trends and alerts.
With the approval, Eversense E3 will be marketed in Germany, Italy, Spain (including Andorra), the Netherlands, Poland, Switzerland, Norway and Sweden.
Ascensia Diabetes Care, the commercial partner of Senseonics, will produce the system and make it available from the third quarter of the year.
The Eversense E3 CGM System is an improved version of the presently available Eversense XL CGM System, which will be retired.
Senseonics president and CEO Tim Goodnow said: “The CE Mark approval for E3 is another demonstration of our commitment to advancing implantable CGM to improve the lives of more diabetes patients worldwide.
“Not only does E3 strengthen our position in the market, but it enables increased operational efficiency as Senseonics will now commercialise the same product iteration globally for the first time.”
In February, the US Food and Drug Administration (FDA) granted approval for the Eversense E3 CGM system.