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FDA  Approves First Implantable Continuous Glucose Monitor

The US Food and Drug Administration (FDA) has approved the first-ever implantable continuous glucose monitoring system, the Eversense CGM (Senseonics), for people aged 18 years and older with diabetes.

The device consists of a fluorescence-based sensor that is implanted subcutaneously in the upper arm by a physician in a short office procedure, a transmitter worn above the sensor, and a mobile app that displays glucose values and trends and that issues alerts to high and low blood glucose values. The transmitter also issues on-body vibration alerts.

In contrast to current continuous glucose monitors (CGMs) that need to be replaced every 7 to 14 days (typically by patients themselves or caregivers), the Eversense lasts up to 3 months, after which it must be removed in another short office procedure — again by a physician — and replaced on the opposite upper arm.