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FDA Advisory Panel Says 'Yes' To Senseonics' Eversense 90-Day CGM Device

30 Mar 2018

• By Sue Darcey

The US FDA Clinical Chemistry and Toxicology Devices Panel unanimously supported Senseonics' Eversense continuous glucose monitoring system for diabetics during a March 29 meeting. The firm currently has a PMA under review for the CGM, which is intended for longer-term use than competitors.

Senseonics Eversense glucose monitoring system device — Eversense device

An FDA advisory panel have its unanimous support to Senseonics Holdings Inc.'s 90-day inserted Eversense CGM system, but also wanted a broadened post-approval study, and registry for Eversense users.

The Clinical Chemistry and Toxicology Devices met to consider the device, which is currently under PMA review for use by...