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Dexcom Receives CE Mark Approval for its Fourth-Generation CGM Sensor

Published: 3/31/11
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Dexcom recently received CE Mark approval for its fourth-generation CGM sensor, clearing the new sensor for use in Europe. The company plans to first feature the sensor in an integrated CGM/pump system developed in partnership with Animas, pending approval of the integrated system currently under review in the European Union. As a reminder, Dexcom's fourth-generation sensor is reported to be more accurate than the SEVEN PLUS (including 25% better accuracy in the hypoglycemic range), 50% smaller by volume, have significantly stronger sensor wires,  a faster startup time (one hour instead of two), and allows for reliable readings sooner after insertion. Dexcom plans to submit the sensor to the FDA in the US by late summer, so our best-case scenario estimates are that the solo sensor could be available in the US by late 2011/early 2012. We expect Animas and Dexcom will submit the integrated system in the US sometime soon after filing the sensor itself. The fourth-generation sensor will also be part of the Dexcom/Insulet integrated system, which is expected to be filed with regulatory agencies in the first half of 2012. –ST

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