Dexcom’s G5® Mobile Continuous Glucose Monitoring System Now FDA-Approved

Dexcom’s G5® Mobile Continuous Glucose Monitoring System Now FDA-Approved

Dexcom, Inc., a leading provider of continuous glucose monitoring (CGM) for patients with diabetes, recently announced the US Food and Drug Administration has granted its Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System approval as a first-of-its-kind fully mobile CGM system for diabetic patients of all ages that sends glucose data directly to a smartphone via Bluetooth.

The system is able to securely transmit vital glucose data to an app on iOS-enabled devices, allowing real-time disease management. An Android counterpart is expected to become available early next year. Similar to its predecessor, the G4 PLATINUM CGM with Share, users of the G5 Mobile CGM System can have as many as 5 data recipients who can monitor the patient’s glucose information remotely.

Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years. The traditional standard-of-care for glucose monitoring has been a finger stick meter. CGM augments the use of glucose meters for the management of diabetes. Meters are still required to calibrate CGMs and for guidance in making therapy and meal decisions. CGM is important because, in addition to providing the glucose level, it provides the direction and rate of glucose change with the push of a button and alerts users when glucose is too low or too high.

“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.  These advances are making diabetes management more convenient and flexible than ever before,” stated Kevin Sayer, President and Chief Executive Officer of Dexcom. “We are excited for the promise this new technology holds for patients and caregivers.”

According to Dexcom, during the G5 Mobile system’s launch, shipping is expected to begin in late September 2015. Those who had purchased the previous system between August 1, 2015 until the official date of the G5 Mobile system’s shipping will be entitled to a complimentary upgrade. Those who bought their G4 systems before this time frame and are still under warranty can upgrade to the new system at a lower cost.

“Obviously there are a lot of moving parts to our commercial launch plans given this sooner-than-expected approval, and the financial ramifications, such as inventory adjustments and revenue recognition policies are being evaluated and will be discussed in detail on the Q3-2015 earnings call in early November,” said Sayer.

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