fingerstick tests

FDA panel advises agency to greenlight Dexcom G5 CGM as replacement to fingerstick treatment decisions

By Heather Mack 12:35 pm July 22, 2016

An FDA advisory panel has voted in favor of recommending a change to the intended use of Dexcom’s G5 Continuous Glucose Monitor (CGM). The G5 had already been FDA-approved, but with limitations as an adjunctive device, meaning it could only be used for tracking and trending interstitial fluid gluocose concentrations rather than as a full replacement for a traditional fingerstick blood glucose...

FDA meeting to weigh whether Dexcom's G5 CGM can replace fingersticks for treatment decisions

By Brian Dolan 04:25 pm June 6, 2016

Next month the FDA is hosting a public advisory committee meeting to discuss a change to the intended use of Dexcom's G5 Mobile Continuous Glucose Monitoring System (CGM) device that would allow the company to market the G5 as a CGM patients can base treatment decisions on. Currently, Dexcom's CGMs are considered adjunctive devices, which means they carry an asterisk that notes they are intended...