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March 25, 2014
08:41 EDTDXCMDexCom receives FDA warning letter for administrative deficiencies
DexCom announced that it has received a warning letter from the U.S. Food & Drug Administration resulting from a November 2013 inspection of the company’s facility in San Diego, California by the FDA’s Los Angeles District Office. The warning letter relates to deficiencies in filing medical device reports involving the company’s continuous glucose monitoring system. Regulations related to MDR reporting were updated by the FDA in July 2013, and during the inspection, the FDA determined that the company was not compliant with these recent updates. There were, however, no sanctions levied by the FDA, nor does the warning letter impact the company’s ability to manufacture and sell its G4 Platinum systems and sensors. Furthermore, the warning letter does not affect any of the company’s pending or future submissions for product approvals. Before the end of April, DexCom expects to submit all materials necessary to demonstrate to the FDA’s satisfaction that the company is in compliance with its reporting obligations in an effort to resolve any remaining deficiencies and close out the warning letter in due course.
News For DXCM From The Last 14 Days
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August 27, 2015
16:16 EDTDXCMDexCom files to sell 404,591 shares of common stock
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August 25, 2015
16:43 EDTDXCMOn The Fly: Top stock stories for Tuesday
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08:32 EDTDXCMDexCom wins FDA approval for G5 mobile continuous glucose monitoring system
DexCom announced that the U.S. Food and Drug Administration has approved the Dexcom G5 Mobile Continuous Glucose Monitoring System. With wireless Bluetooth technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. The new transmitter securely sends vital glucose information directly to an app on iOS-enabled devices for real-time diabetes management. Android applications will follow early next year. Like its predecessor, the G4 PLATINUM CGM with Share, users can also select up to five designated recipients, or "followers". These followers can remotely monitor a patient's glucose information and receive alert notifications from almost anywhere.
08:32 EDTDXCMDexCom says FDA approves G5 Mobile Continuous Glucose Monitoring System
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August 24, 2015
08:29 EDTDXCMWilliam Blair to hold a field trip
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