Long-term implantable CGM gets FDA approval

Create PDF

The FDA evaluated clinical study data from 125 adults with diabetes and reviewed the device’s effectiveness by comparing readings obtained by Eversense with those obtained by a laboratory-based glucose analyzer. The safety of the system’s 90-day implantable sensor and the procedure used to implant it were also evaluated. The FDA held an advisory committee meeting to provide an independent assessment of the safety and effectiveness of the system. In an eight-to-zero vote, the committee recommended that the benefits of the system outweigh the risks for patients with diabetes.

Senseonics, 301-515-7260