Dexcom to resubmit G7 glucose monitor software for FDA review, pushing back US launch was posted by Conor Hale for FierceBioTech.Com, 29 July 2022.
Diabetes tracker developer Dexcom is pushing back the timeline for a U.S. launch of the latest generation of its continuous glucose monitor, the G7 after the FDA raised questions about the device’s software during a review. Though the wearable sensor was first submitted to the agency late last year, the company now plans to rework how the G7 and its smartphone apps deliver alarms to alert the user of significant changes in their blood sugar.
“We discussed several options that we had, and we decided the best option at this time was to revise the software and file it differently and we have added a few other features to it as well based on our discussions with them,” CEO Kevin Sayer. Comparing the latest version to its mainstay G6, the G7’s development had already brought on a complete revamp of the company’s processes.