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Dexcom gets FDA approval for G5 Mobile CGM system

8/25/2015


SAN DIEGO — Glucose monitoring device company Dexcom announced Tuesday that the Food and Drug Administration had approved its G5 Mobile Continuous Glucose Monitoring System.


Earlier this year, the company received FDA approval for G4 Platinum CGM with Share, but that system required a separate receiver that would then relay information to a user’s phone and up to five followers. With G5 Mobile, information goes directly from the transmitter to the compatible smartphone app. With the G5 system, users can still share their monitoring information with family members or caregivers.


“Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management.” Dexcom president and CEO Kevin Sayer said. “Since January, the company has introduced the G4 Platinum CGM with Share, apps to enable the first CGM on the Apple Watch and now the Dexcom G5 Mobile CGM. These advances are making diabetes management more convenient and flexible than ever before.”


The G5 Mobile system will begin shipping in late September and those who purchased a G4 Platinum with Share system beginning Aug. 1 through the G5 Mobil ship date will be eligible for a free upgrade to the new system. Those whose other Dexcom devices are still under warranty can updgrade for fee, the company said.


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