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www.fdanews.com/articles/168376-fda-approves-dexcoms-glucose-monitoring-software-with-artificial-pancreas-algorithm

FDA Approves Dexcom’s Glucose Monitoring Software With Artificial Pancreas Algorithm

November 7, 2014

Continuous glucose monitoring systems maker Dexcom said the FDA had approved new software for the Dexcom G4 Platinum CGM. The new software uses the same algorithm as used in artificial pancreas research, and will be available free of charge to patients using the G4 Platinum, the company said.

“Patients will be able to go online and download the software, or they will receive the software preloaded onto their Dexcom receiver with new orders,” said Dexcom CEO Terrence Gregg. He added that the software will make the performance level comparable to episodic blood glucose finger sticks, and give readings close to lab accuracy.

The G4 Platinum is already the most accurate CGM system available, the San Diego, Calif., company said, adding that this technology will help make CGM the standard-of-care over blood glucose meters for people with diabetes. — Kellen Owings

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