FDA Advisory Panel Says 'Yes' To Senseonics' Eversense 90-Day CGM Device
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.
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US FDA approved the Eversense CGM System for continually measuring glucose levels in adults with diabetes for up to 90 days, and the company is working on clinical evidence to support a 365-day indication, as well as working with Roche and Beta Bionics to include its sensor technology in fully integrated artificial pancreas systems
ADA2018: Senseonics' Implantable CGM Beats Abbott, Dexcom In Head-To-Head Study – But Is Methodology Flawed?
In a three-way patient study comparing the accuracy of three currently available continuous glucose monitoring (CGM) devices, the newly FDA-approved Eversense by Senseonics performed significantly better than the Abbott Freestyle Libre Pro and Dexcom G5. The study findings were presented during this year's annual American Diabetes Association meeting in Orlando, Florida. This article also discusses other highlights presented by the three companies at the ADA conference.
US FDA recently approved the first 90-day CGM system and expanded the labeling for a closed-loop system to treat diabetes.