DexCom said it won pre-market approval from the FDA for its Dexcom G4 Platinum Professional continuous glucose monitor, touting it as the only professional-version CGM to offer real-time, unblinded feedback for patients and caregivers.
Patients use the G4 Platinum Professional CGM for 7 days as the device logs the rate and direction of glucose changes every 5 minutes.
"Dexcom’s mission is to provide doctors, patients and caregivers new medical technology to improve their understanding and management of diabetes," CEO Terrance Gregg said in prepared remarks. "The G4 Platinum Professional is Dexcom’s latest answer for healthcare professionals and patients seeking novel and insightful tools to optimize therapeutic decisions."
"Professional CGM provides healthcare practitioners and patients the necessary data to plan treatment and lifestyle decisions to keep glucose at safe levels, in the reference range found in persons without diabetes," added Dr. Lori Laffel of the Joslin Diabetes Center in Boston. "The ability to rapidly deploy and translate this data for the better of patients is a valuable instrument in the management of diabetes."
Earlier this year DexCom won a PMA from the watchdog agency for the G4 Platinum for diabetic children ages 2 to 17. In March the FDA issued a warning letter to DexCom for failing to report at least 4 incidents of low blood sugar requiring medical treatment and 1 instance in which its blood glucose monitor shocked a patient.