FDA allows implantable CGM to integrate with insulin pumps

The US Food and Drug Administration (FDA) has designated the Eversense (Senseonics, Inc; Ascencia Diabetes Care) implanted continuous glucose monitor (CGM) as an ‘integrated CGM,’ which means that it can be used with insulin pumps as part of an automated insulin delivery system (AID).

The Eversense device joins Dexcom’s G6 and G7 and the Freestyle Libre 2 Plus in being compatible with multiple different branded insulin pumps as part of AID systems. It is the only implantable one: its sensor is inserted under the skin of the patient’s upper arm by a healthcare provider, and a transmitter is worn over it on the skin.

According to Senseonics, the Eversense is “the most accurate CGM in the critical low glucose ranges with essentially no compression lows.” The latter refers to ‘false low’ alarms that sometimes occur when a person presses on the device, such as while asleep.

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