Senseonics Wins Marketing Authorization For Novel Insulin Delivery System

The Food and Drug Administration has authorized marketing for the Eversense AP CGM System from Senseonics. The combination product includes a fully implantable sensor with an anti-inflammatory drug — dexamethasone acetate — that is slowly released onto the skin to reduce inflammation at the sensor insertion site.

As the first fully implantable device in the category, the FDA says the authorization establishes the system as a predicate for future iCGM (integrated continuous