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Glucose Monitoring, Topics

June 21, 2018

Senseonics Eversense CGM approved in the US; sPMA for insulin-dosing claim to follow

Here is a brief preview of this blast: Senseonics has announced approval of Eversense, their implantable CGM, in the US and held an investor call. Of note, Senseonics did not mention anything regarding the updated components discussed during the adcom (sensor end cap and insertion tool); however, it was approved with the smaller gen 2 transmitter. Below, FENIX has conducted an analysis of the approval, safety labeling, and market implications.