FDA Will Allow Marketing of Novel Interoperable Continuous Glucose MonitorMarch 29, 2018
The Food and Drug Administration (FDA) has granted a De Novo classification request for the Dexcom G6 integrated continuous glucose monitoring (iCGM) system (Dexcom, Inc.), allowing the device to be marketed in the U.S. for determining glucose levels in patients with diabetes who are ≥ 2 years of age. The novel iCGM system is classified as a class II device and is subject to special controls; future iCGM products that meet the special controls criteria are now eligible for a 510(k) clearance review.
According to an FDA news release, the Dexcom G6 is the first type of CGM system authorized for sale by the agency that can be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management.
The Dexcom G6 is a patch device that is applied to the skin of the abdomen. It contains a small sensor that continuously measures the amount of glucose in body fluid, transmitting real-time glucose readings every 5 minutes to a compatible display device such as a mobile medical app on a cell phone.
Unlike the earlier generation Dexcom G5 system, which the FDA approved in 2016, the Dexcom G6 is factory calibrated and does not require users to calibrate the sensor with fingerstick blood glucose measurements. In addition, the Dexcom G6 has an updated sensor probe that minimizes interference with acetaminophen.
Dexcom, Inc. expects to launch the G6 iCGM system later this year.
Food and Drug Administration (FDA). FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices [news release]. March 27, 2018. Available at: click here. Accessed March 28, 2018.