DexCom Inc. (NSDQ:DXCM) said it secured FDA approval for its DexCom G4 Platinum continuous glucose monitor for diabetic children ages 2 to 17.
The G4 device is an externally worn system that features enhanced accuracy, an LCD color display, a smaller profile and a unique “hypo alert” setting that provides increased security. It was originally approved in October 2012.
The additional indication allows for children to be able learn how to manage their diabetes into adulthood. The G4 is the only continuous glucose monitor for pediatric patients, according to a press release.
Although a pivotal trial found that the G4 had problems detecting hypoglycemia detection, “particularly at blood glucose concentrations below 70 milligrams per deciliter of blood,” an FDA review found that "the study did demonstrate that the device is effective for tracking and trending to determine patterns in glucose levels, and for alerting patients when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels," according to a release from the watchdog agency.
“We are thrilled with the FDA’s approval of our Dexcom G4 Platinum system in the pediatric population. Daily management is relentless, and parents can now have greater peace of mind that a child’s diabetes is under control, whether the child is at home, away at school, or participating in activities or sports. The Dexcom G4 Platinum provides dynamic glucose information harnessing today’s most innovative technology, so that persons with diabetes can go about their daily lives without added worry,” DexCom CEO Terrance Gregg said in prepared remarks.
San Diego-based DexCom beat Wall Street’s expectations during the 4th quarter, with sales of roughly $51 million up 61% over the same period in 2012 – and well ahead of a $46 million forecast on The Street. Full-year 2014 sales are pegged at $157 million, representing a 69% gain over 2012.
