Cellnovo Group provided an update regarding the review by the U.S. Food and Drug Administration (FDA) of the company’s 510(k) application for clearance of the Cellnovo Diabetes Management System. Cellnovo filed a 510(k), a premarket submission that is required before a medical device can be marketed in the US, with the FDA on November 16, 2016. On August 8, 2017, Cellnovo responded to an initial series of questions from the FDA relating to the application. Cellnovo can report that since this submission, the FDA has responded requesting further information to supplement that already provided by the Company. The company expects this new step will extend the previously expected timeline for clearance of the device in the U.S. and will continue to keep the market informed of progress.