Congratulations to Dexcom, our longtime client: the FDA granted Dexcom a de novo request earlier this week for the G6 continuous glucose monitor (CGM) system, their newest generation of a system that has been on the market since 2006. On the G6, NOVO performed initial concept development, feasibility prototypes, and early-stage development. We also co-developed earlier generations of the device.

Because the intended use of the G6 is a seamless integration with other diabetes devices, it was granted a de novo premarket review, allowing it to be considered for Class I or Class II medical device status with special controls. This status allows more expeditious approval of future CGM systems via a 510(k) clearance. The G6 is the first CGM to be granted de novo classification.    

The G6 does not require any regular calibration from a finger-prick. It also displays real-time glucose data on smart mobile devices via the Dexcom G6 app. The applicator NOVO helped design allows for simple, single-touch insertion.  

We value our long-term relationship with Dexcom and look forward to seeing how their CGM technology can continue to help patients with diabetes.

Read more about our work on the G6 in our portfolio.

Visit Dexcom’s G6 product page.