Sam Brusco, Associate Editor06.16.22
Senseonics has earned CE mark approval for its next-gen Eversense E3 implantable glucose monitoring (CGM) system. The system, which can be used for 6 months, will be available in the EU from the third quarter of this year.
“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 commercialize the same product iteration globally for the first time,” Tim Goodnow, Ph.D., president and CEO of Senseonics told the press. “We are excited for Ascensia to continue to build on the momentum of the E3 launch in the U.S. as they commercialize the improved system in European markets in the coming months.”
Eversense E3’s sensor lowers frequency of calibration and has enhanced longevity. It’s also been approved for non-adjunctive use, meaning readings are provided from the system to inform insulin treatment decisions without fingerstick testing confirmations.
Eversense E3 received FDA approval and launched in the U.S. earlier this year. Following CE mark approval, it will be rolled out in Germany, Italy, Spain (including Andorra), the Netherlands, Poland, Switzerland, Norway, and Sweden.
Read about more innovative technologies to manage diabetes here!
“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 commercialize the same product iteration globally for the first time,” Tim Goodnow, Ph.D., president and CEO of Senseonics told the press. “We are excited for Ascensia to continue to build on the momentum of the E3 launch in the U.S. as they commercialize the improved system in European markets in the coming months.”
Eversense E3’s sensor lowers frequency of calibration and has enhanced longevity. It’s also been approved for non-adjunctive use, meaning readings are provided from the system to inform insulin treatment decisions without fingerstick testing confirmations.
Eversense E3 received FDA approval and launched in the U.S. earlier this year. Following CE mark approval, it will be rolled out in Germany, Italy, Spain (including Andorra), the Netherlands, Poland, Switzerland, Norway, and Sweden.
Read about more innovative technologies to manage diabetes here!