Senseonics Eversense granted integrated CGM designation by FDA

Senseonics announced that Eversense has been granted an integrated CGM, or iCGM, designation by the FDA. Eversense has been authorized to be marketed as an iCGM through the FDA’s De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future for devices of the same type.