US-based Dexcom has obtained the US Food and Drug Administration (FDA) approval for its Dexcom G4 Platinum (pediatric) continuous glucose monitoring (CGM) device for use in children ages 2–17 years with diabetes.
The device has already obtained FDA approval for use in adults aged 18 and older. The company claims that the Dexcom G4 Platinum (pediatric) is the only CGM system approved by the FDA for children as young as two years old.
Dexcom CEO Terrance H Gregg noted the company is thrilled with the FDA’s approval of its 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," Gregg added.
The Dexcom G4 Platinum features a built-in alarm, which notifies users when glucose levels fall to critically low levels for an additional level of awareness.
The device measures glucose levels continuously for seven days throughout the 24-hour period using wireless technology, enabling users to view their glucose levels on demand. It allows diabetic patients to program personalized information, such as glucose targets and alerts.
Dexcom G4 Platinum (Pediatric) features an extended 20ft wireless transmission range without obstruction for added flexibility.