Dexcom G7 Continuous Glucose Monitor Receives FDA Clearance

Dexcom announced last week that its G7 Continuous Glucose Monitoring System had received FDA clearance.

The latest model of its CGM, which can be used by people with all types of diabetes from the age of 2, is expected to launch in the United States early next year. As the company builds insurance coverage for the G7, it plans to offer cash payment options to early adopters.

The CGM fits on the back of the upper arm or upper buttocks for pediatric patients if they prefer, and sends glucose readings to a compatible smart device or a Dexcom receiver.

Dexcom touts a sensor warm-up of 30 minutes for the G7, which it compares to an hour or more for competing CGM brands. It also offers customizable alerts for high or low blood sugar and a predictive alert that can offer a 20-minute warning before potentially dangerous blood sugar levels.

The company said it is working with insulin pump vendors to integrate the G7 into current and future automated delivery systems.

“When we set out to design G7, our goal was simple: to provide people with diabetes, whether type 1 or type 2, with the most powerful and easy to use CGM. G7 stands fulfill that promise. And now that it has been cleared by the FDA, we look forward to bringing G7 to market in the coming months,” Dexcom Chairman and CEO Kevin Sayer said in a statement.

THE GREAT TREND

Dexcom first filed for regulatory clearance in the fourth quarter of last year. The exit of the G7 has been delayed after the FDA came back with questions about the device during its review, prompting a software update. The G7 received a European CE mark in March of this year.

Dexcom’s previous CGM model, the G6, received the green light from the FDA in 2018. As the The FDA said the G6 was the first system to be used with other compatible medical devices and electronic interfaces, such as automated insulin dosing systems, insulin pumps and blood glucose meters.

“In addition to being interoperable and connectable, we’ve also improved cybersecurity here,” Sayer said. Told MobiHealthNews in January. “We’ve really embraced new technology. Our circuitry and chip in the G6 was developed in 2016-2017, and cybersecurity and Bluetooth have advanced significantly since then. So the new chips we have in this system will make again feel people safer.”