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Medical Devices / Submissions and Approvals

Senseonics’ Eversense Recommended for Approval by FDA

April 4, 2018
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Senseonics received a unanimous recommendation for approval from an FDA advisory panel for its implantable continuous glucose monitor for use in adults with diabetes.

The device is a fluorescence-based system that is implanted in the upper arm in a 5-to-10 minute office-based procedure. The implanted sensor lasts ninety days after which it is removed with another short procedure and replaced.

An external transmitter is taped on the skin above the implant to allow the glucose monitor to work with its accompanying smartphone or tablet mobile app, which displays and stores the glucose readings.

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