Dexcom G6 gets FDA nod

Dexcom

“Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring iCGM devices’ accuracy, reliability and clinical relevance as well as describe the type of studies and data required to demonstrate acceptable iCGM performance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this device.”

The FDA evaluated data from two clinical studies of the Dexcom G6, which included 324 adults and children aged 2 years and older with diabetes. Both studies included multiple clinical visits within a 10-day period where system readings were compared to a laboratory test method that measures blood glucose values. No serious adverse events were reported during the studies.

msullivan@MDedge.com