FDA clearance for the highly anticipated device covers people with all types of diabetes aged 2years and older.
San Diego-based Dexcom’s device features a 60% size reduction from the previous generation, the G6. It offers a 30-minute warmup period (down from waiting two hours for glucose readings to begin in the past).
G7 provides more information in one place with personalized insights, extended-wear design and more. It features a simple wear experience, starting with unscrewing a cap. The user then puts the sensor on their body and pushes a button. The device is then turned on and can be paired with a smartphone.
The Dexcom G7 demonstrated exciting results in glucose monitoring in a number of recent clinical trials. One study highlights its accuracy, and another demonstrates strong performance in pediatric users. Dexcom announced the international rollout of the next-generation Dexcom G7 CGM in October. The system won CE mark in March.
In order to pick up FDA clearance, Dexcom had to apply software tweaks based on FDA feedback earlier this year. This threw a wrench in the expected timelines for FDA 510(k) clearance and the subsequent U.S. launch.
DXCM shares were up more than 4% at $123.08 apiece near the close of trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 7%.