Cellnovo Group (“Cellnovo” CLNV:EN Paris), a medical technology company marketing the first mobile, connected, all-in-one diabetes management system, announces today that it has filed for 510(k) approval with the US Food and Drug Administration (FDA) for marketing clearance of the Company's diabetes management system.
The 510(k) is a premarket submission that must be filled with the FDA before a medical device can be launched and marketed in the US.
Cellnovo can confirm that the submission is under review by the FDA, a process that the Company expects to last several months. In anticipation of 510(k) approval, Cellnovo will continue preparations to ensure readiness for launch of the system in the US, the world’s largest single market for medical devices.