With this designation, Eversense becomes the first fully implantable device in the category. Senseonics can now market the long-term CGM through the FDA’s de novo pathway. This establishes the special controls serving as a predicate device for future 510(k) submissions.

iCGM status indicates that Eversense can integrate with compatible medical devices. That includes insulin pumps as part of an automated insulin delivery system. Senseonics and Ascensia Diabetes Care, its distribution partner, plan to advance partnership discussions with pump manufacturers.