Dexcom Ends the Year with FDA Nod for G7Dexcom Ends the Year with FDA Nod for G7

One of the most anticipated devices in medtech has finally won a nod from FDA. Dexcom closes out 2022 with clearance for the G7 Continuous Glucose Monitor after facing a few delays.

The device is cleared for people with all types of diabetes ages two and older. The San Diego, CA-based company has had CE Mark for the device since March.

“There’s a reason Dexcom has the best-selling real-time CGM on the market,” Kevin Sayer, chairman, president and CEO of Dexcom, said in a release. “For more than a decade, we’ve pioneered generation after generation of sensing technology that consistently delivers improved accuracy, reliability and a simpler user experience, giving people greater control of their diabetes. When we set out to design G7, our goal was simple: to make the most powerful, easy-to-use CGM available for people with diabetes, whether they have Type 1 or Type 2. G7 delivers squarely on that promise. And now that it has been cleared by FDA, we look forward to making G7 commercially available in the coming months.”

The company touted G7 as having an overall MARD of 8.2%, and the CGM is clinically proven to lower A1C, reduce hyper- and hypoglycemia and increase time in range.

In October, the company held a livestream that discussed the design of the G7 and how it address pain points in CGM use. The company said that changing the sensor is one example. He noted the device offers a 12-hour grace period for changing a sensor to give Dexcom customers some flexibility.

Dexcom filed with FDA late in 2021. However, the device was delayed because of a backlog the agency was experiencing because of the pandemic. Then in July, it was revealed FDA was requesting Dexcom make subtle delays to the software, which caused even more delays.

The delay gave Dexcom’s rival, Senseonics, a longer runway in the CGM market. The Germantown, MD-based company had won a nod from FDA in February for Eversense, its 180-day CGM sensor. Senseonics launched Eversense in April.

Sayer spoke with Let’s Talk Medtech shortly after the 82nd Scientific Sessions of the American Diabetes Association about some of Dexcom’s accomplishments and how its setting itself apart from other players in the CGM space.