FDA approves Dexcom G4 platinum system

26 January 2015 (Last Updated January 26th, 2015 18:30)

The US Food and Drug Administration (FDA) has granted approval for Dexcom's G4 platinum continuous glucose monitoring system with share receiver.

Dexcom G4

The US Food and Drug Administration (FDA) has granted approval for Dexcom's G4 platinum continuous glucose monitoring system with share receiver.

In order to transmit glucose information to apps on mobile devices of up to five designated recipients or followers without the need for a docking cradle, the share receiver uses a secure wireless connection through bluetooth low energy between a receiver and an app on the smartphone.

According to the company, these followers can remotely monitor patients' glucose information and receive alert notifications via the Apple iPhone or iPod touch, as well as on Android devices in the future.

The FDA reviewed the mobile app software used with the receiver through its de novo classification process, a regulatory pathway for low to moderate-risk medical devices that are new and not substantially equivalent to any legally marketed device.

Dexcom president and CEO Kevin Sayer said: "The Dexcom share receiver represents a significant step forward for our company and our mobile strategy, but more importantly, it will provide a huge improvement for people managing their diabetes and for those parents and care givers who help them each and every day.

"The FDA understands the importance of this type of innovation and the need to regulate it appropriately."

"The FDA understands the importance of this type of innovation and the need to regulate it appropriately, and we could not be more pleased with the speed at which they reviewed and approved this important innovation."

The company intends to commercialise the receiver in early March.

The FDA has specifically classified the apps, which communicate with the receiver, as secondary display devices.

Similar devices, which provide only secondary display for passive monitoring, but which do not replace the primary real-time display device, will be subject to the same classification and compliance with certain special controls.


Image: Dexcom's G4 system uses bluetooth low energy to transmit glucose information to apps on mobile devices. Photo: courtesy of Dexcom, Inc.