Dexcom G5 Mobile CGM system clears the FDA

Dexcom G5 Mobile CGM system

FDA has approved the Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) system, making it the first and only “fully mobile” CGM system approved by the agency for both adults and children.

The device boasts and integrated transmitter that 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 FDA-cleared G4 PLATINUM CGM with Share, users can also select up to five designated recipients, or “followers,” who can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere.

“Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. 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,” said Kevin Sayer, President and CEO of Dexcom. “These advances are making diabetes management more convenient and flexible than ever before.”

The G5 Mobile system is anticipated to begin shipping in late September 2015.The G5 Mobile system is anticipated to begin shipping in late September 2015. All purchasers of a G4 Platinum with Share system from August 1, 2015, until the G5 Mobile system is shipped, will be eligible to receive a no-cost upgrade to the G5 Mobile system. Also, there will be an affordable upgrade to the G5 Mobile system for those users who are still under warranty with their existing system.

The Dexcom G5 Mobile CGM System features what the company says is the “most accurate glucose sensor on the market” while providing enhanced mobility and flexibility to view and share personal glucose data and trends. Dexcom can obviously make such claims since it has recently partnered with Google to develop a series of CGM products designed to be smaller and less expensive than existing technologies.