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

 
• 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 diabetics who are 18 years and older. In a series...

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