FDA clears one-year CGM

Senseonics and its commercial partner Ascensia Diabetes Care have received clearance from the Food and Drug Administration for the first implantable glucose sensor that can be worn for one year, doubling the wear time of Senseonics’ current sensor.

The continuous glucose monitor (CGM), called Eversense 365, is implanted just under the skin. A removable transmitter is worn on top of the skin using adhesive. It can be used by adults with Type 1 or Type 2 diabetes.

Eversense 365 has an integrated CGM designation, which means that it can be used as part of an automated insulin delivery system, when a CGM and insulin pump coordinate to deliver insulin, and the company is in partnership discussions with pump manufacturers,

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