Senseonics Nabs CE Mark for Extended-Life CGM, according to FierceBiotech, 9/13/2017.
The new system has a glucose sensor that lasts up to 180 days, double the life of the system it already markets, which has a sensor that may be used for up to 90 days. In addition to the long-term implantable sensor, the Eversense XL Continuous Glucose Monitoring System comprises a transmitter and a mobile app that displays real-time glucose data. The company plans to roll the product out in Europe in the fourth quarter this year, according to a statement. Senseonics, based in Maryland, signed a distribution deal with Roche for marketing in Germany, Italy and the Netherlands. Additionally, their partnership expanded to include TypeZero Technologies for a long-term, closed-loop system.
FDA Approves Abbott Freestyle Libre Flash, as reported on InsulinNation.com, 29 September 2017. And that announcement seems to be shaking up the CGM world!
On September 27th, the FDA announced that the Abbott Freestyle Libre Flash glucose monitoring system would be cleared to enter the U.S. marketplace. The Libre Flash differs from all other wearable glucose monitoring systems for people with diabetes in that it does not require fingerstick calibration and it utilizes a sensor that can be worn for up to 10 days. The Libre Flash differs from continuous glucose monitors on the market in that it does not provide glucose readings without an outside prompt from another device scanned on the sensor. Users of the Libre Flash wear a sensor below the skin’s surface to monitor their glucose levels; they then wave a specially designed mobile reader to see their readings and trends.
The following day, shares of Dexcom slipped sharply, declining by more than 36%. Unfortunately, DexCom is about a year away from bringing a similar no-calibration (and hence, no finger-stick) device to market, and that lag could spell disaster for the CGM specialist.