The U.S. Food and Drug Administration signed off on San Diego-based Dexcom’s G6 diabetes monitoring system, which doesn’t require finger prick blood draws for calibration, it was announced March 27.
G6, about the size of a quarter, is worn on the abdomen and contains a small sensor that continuously measures glucose, transmitting real-time readings to a smartphone. An alarm goes off if a patient’s blood sugar goes too high or low.
There is competition: A few months ago, Abbott Laboratories’ Freestyle Libre won FDA approval for a system that also doesn’t involve finger pricks. But Dexcom has argued it has unique features, such as the ability to remotely share glucose readings with friends, family and caregivers.
G6 is also critical for a “closed loop” system, which automatically delivers insulin. Dexcom has worked with San Diego pump maker Tandem Diabetes Care on the technology.
To that end, G6 marks the first continuous glucose monitoring system with FDA approval for use with compatible medical devices, such as automated insulin dosing systems and insulin pumps, the agency stated.
"The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences," said Donald St. Pierre with the FDA's Center for Devices and Radiological Health.
In addition, the FDA’s decision assigned G6 a special classification. This paves the way for future makers of such systems to come to market in the “least burdensome manner possible,” the agency stated.
Dexcom’s shares on March 27 increased nearly 3 percent to heights of $72.52 and were at $71.02 in after-hours trading.
Read more about what’s next for Dexcom in this profile of CEO Kevin Sayer.