Senseonics Holdings, Inc. announced that Eversense® has been granted an integrated CGM (iCGM) designation by the U.S. Food and Drug Administration (FDA). As the first fully implantable device in the category, 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. iCGM status indicates that Senseonics?

Eversense iCGM product can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system. The companies plan to advance partnership discussions with various pump manufacturers, with plans to offer people who choose to integrate their diabetes devices a new interoperable CGM option that is exceptionally well suited for AID systems. This is because Eversense addresses common limitations of AID systems outlined in the 2022 Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association. Designed by Senseonics and brought to people with diabetes by Ascensia, the Eversense CGM System offers a fully implantable option that is exceptionally well suited for AID therapy: The longest lasting CGM available with 6 months of wear time and only one insertion and one ?Day 1?.

Most accurate CGM in critical low glucose ranges2,3,4,5 with essentially no compression lows. Most dependable CGM alert detection to support accurate corrections in real time. The only CGM with a removable transmitter which can be taken on and off without wasting a sensor or adding a warm up period.