FDA approves DexCom’s CGM system with Share

3/4/2015

 



SAN DIEGO — DexCom received Food and Drug Administration approval for its Dexcom G4 Platinum Continuous Glucose Monitor System with Share. According to the company, the Share receiver uses a wireless connection via Bluetooth Low Energy between the patient’s receiver and an app on the patient’s smartphone to relay glucose information to apps on the mobile devices of up to five designated recipients, or “followers.”


The “followers” can monitor apatient’s glucose information remotely and also can receive alert notifications. The “Share” and “Follower” apps will be available via Apple’s App Store at no cost. 


The company also released the following information regarding the Dexcom G4 Platinum with Share:




  • The Share receiver is anticipated to ship to new patients in early March 2015;


  • All patients who purchased a Share cradle will receive a free upgrade to the Share receiver;


  • All purchasers of a G4 Platinum receiver from January 1, 2015, until the Share receiver is shipped, will receive a free upgrade to the Share receiver;


  • There will be a low cost cash upgrade to the Share receiver for those patients who are still under warranty with their existing receiver; and


  • The Share receiver will be compatible with future generation Dexcom sensor systems.


“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 caregivers who help them each and every day,” said Kevin Sayer, president and CEO of Dexcom. “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.”



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