DexCom: CE Mark Approval for Continuous Glucose Monitor

DexCom’s short term continuous glucose monitor, The Seven, has received CE Mark approval enabling commercialization in the EU and the countries in Asia and Latin America that recognize the CE Mark. The company will initiate a limited launch in Europe before the end of 2008 with a more robust launch following in 2009.

The Seven’s probe-like sensor is inserted under the skin by the user and is held in place by an adhesive. A transmitter sends the glucose signal from the sensor and wirelessly transmits the data to a hand-held receiver. The receiver processes the glucose signal and, with the push of a button, displays the user’s current glucose value, as well as 1-hr, 3-hr, and 9-hr trends. The receiver also sounds an alert when a high or low glucose excursion is detected.

Clinical research has demonstrated that users show statistically significant improvements in glycemic profiles with no guidance or therapeutic adjustments from physicians. Users were able to reduce time spent hyperglycemic and hypoglycemic, while simultaneously increasing time spent in their target glucose range. Diabetes affects an estimated 246 million people worldwide, according to the International Diabetes Federation.

Previously: [Video Profile] Interview with Terrance Gregg, President & CEO of DexCom

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