www.fdanews.com/articles/208831-dexcoms-next-generation-g7-device-clearance-snagged
Dexcom’s Next-Generation G7 Device Clearance Snagged
August 2, 2022
Dexcom’s pathway to FDA clearance for its next-generation Dexcom G7 continuous glucose monitoring system has hit a software snag, the company said.
In response to feedback from the agency, the company has been tweaking the supporting software and said it now expects the agency to make a decision on the submission later this year.
The latest Dexcom G7 features a smaller sensor than its predecessor, making it more convenient to monitor and manage glucose in diabetes patients.
The device has already received CE-mark certification in Europe.