FDA Approves Dexcom G6, Streamlines Review for Similar Interoperable CGMs

Along with this marketing approval, the FDA also determined that such products could henceforth be classified as "moderate risk" class II medical devices with special controls.

The U.S. Food and Drug Administration (FDA) gave a green light on Tuesday to an integrated continuous glucose monitoring (iCGM) system for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes. An earlier version, the Dexcom G5, won FDA approval in 2016 but was not designed as an integrated system to be used with compatible devices. Replaced every 10 days, the device is applied to the abdomen and transmits real-time glucose levels, via a small sensor that continuously measures the amount of glucose in body fluid, to a mobile medical app. This authorization serves to streamline and expedite the regulatory review process for developers of future iCGM systems who are seeking marketing authorization. The Dexcom G6 is 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, including mobile health apps. If it's integrated with an automated insulin dosing system, a rise in blood sugar would trigger the release of insulin from the pump.

Donald St. Pierre, the acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said that the device's interoperable capability "gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences".

Other continuous glucose monitoring systems have been evaluated through the FDA's class III medical device pathway-for high risk devices-but according to the agency, the Dexcom's interoperability with other devices places it in a lower tier. This newest model comes factory calibrated, meaning patients will not need to use fingerstick blood measurements to adjust the sensor. In addition, it has an updated sensor probe that minimizes interference with the pain reliever acetaminophen.

Dexcom G6 was evaluated in 2 clinical studies (N=324) that included adults and children aged ≥2 years with diabetes. There were no serious adverse events reported during the trials.

Notícias recomendadas

We are pleased to provide this opportunity to share information, experiences and observations about what's in the news.
Some of the comments may be reprinted elsewhere in the site or in the newspaper.
Thank you for taking the time to offer your thoughts.