Dexcom G5 APPROVED by FDA!
All text taken from the Dexcom press release that can be found in its entirety but this is the stuff you want to know. When you are finished reading this you can check out Dexcom's new G5 webpage.
SAN DIEGO, Aug. 25, 2015 /PRNewswire
FDA Approves Dexcom G5® Mobile Continuous Glucose Monitoring System
Image from Dexcom.com
Dexcom announced today that the U.S. Food and Drug Administration (FDA) has approved the Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) 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.
About the Dexcom U.S. G5 Mobile Launch
- 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.
- There will be a low cost cash upgrade to the G5 Mobile system for those patients who are still under warranty with their existing system.
Image from Dexcom.com
"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," remarked Sayer.
“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... We are excited for the promise this new technology holds for patients and caregivers.”
I'm working on getting you some G5 images, in the meantime check out the link below for my recent podcast conversation with Dexcom CEO Kevin Sayer... back soon.
Great news for the type diabetes community!
