After plenty of anticipation — and a bit of waiting — the next-generation Dexcom G7 continuous glucose monitor is finally here.
In mid-2021, Dexcom (Nasdaq:DXCM) CEO Kevin Sayer told Drug Delivery Business News that its next-generation CGM would be “wonderful.” At the time, he said enthusiasm over the Dexcom G7 sat at an all-time high.
About 18 months later, the Dexcom G7 finally arrived in the U.S. The FDA granted clearance to the device earlier this month.
The Dexcom G7 demonstrated exciting results in glucose monitoring in a number of clinical trials. One study highlights its accuracy, and another demonstrates success with pediatric users. Dexcom announced its international rollout for G7 in October. The system won CE mark in March.
In order to pick up FDA clearance, Dexcom had to apply software tweaks based on FDA feedback earlier this year. This threw a wrench in the expected timelines for FDA 510(k) clearance and the subsequent U.S. launch.
Now that the long-awaited FDA clearance arrived, COO Jake Leach shared the company’s excitement.
“It’s one of those milestones that you remember,” Leach told DDBN. “All along the product development, you’re working towards getting approval from a regulatory agency so you can market it. We got CE mark earlier this year, and then it was really nice to get FDA clearance before the end of the year. It sets us up really well to launch the product early next year.”
Get the full story at our sister site, Drug Delivery Business News.