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« DexCom G4 Platinum Overview | Main | I know what the FDA will say and I don't care »
Monday
Oct082012

FDA Approves DexCom G4 Platinum CGM

 

Arden has been using the DexCom 7+ for over two years and I don't remember how we did all of this without it. That's why I'm so excited to say that DexCom just announced that their newest version, the "G4 Platinum" has been APPROVED by the FDA. A review of the press release tells me that the company has made improvements in accuracy exactly where they were needed most. The release says in part:

 

Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.

"Improved accuracy in the critical hypoglycemic range is most important from a life-saving point of view," said Terrance H. Gregg, DexcomCEO. "The Dexcom G4 PLATINUM fulfills the promise of CGM for people with diabetes by providing accurate and reliable real-time performance."

 


 

In addition to accuracy improvements the release also highlights these new capabilities:

 

  • Longest transmission range, enabling improved patient flexibility and convenience
  • A smaller, discrete profile that fits busy lifestyles
  • A first-of-its-kind color LCD display for easy viewing
  • Customizable alerts with specific tones
  • "Hypo alert" setting at 55 mg/dl that provides an increased level of safety — a feature that no other device has.

 

You can read the entire press release here.

Crossing my fingers that they thought about remote monitoring... 

 

* I was able to find images from a site used to register for a recent DexCom symposium in Berlin, but they are low res. I'm working on finding better ones and will let you know when I do.

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