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Cellnovo Group announces 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.
Sophie Baratte, Chief Executive Officer of Cellnovo, commented: “We are pleased to have submitted our application to the US authorities. The United States represents an important future market for Cellnovo with 1.25 million children and adults with type 1 diabetes*. Furthermore, market penetration of insulin pumps is higher in the US than anywhere else in the world. We believe that our diabetes management system, offering unrivaled levels of freedom and connectivity combined with high levels of accuracy, has the potential to perform strongly in the growing insulin-pump marketplace.”
