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Medical Devices / Inspections and Audits

FDA Finds Eversense CGM Sensor Is Safe for MRIs

Feb. 5, 2019

The FDA determined that patients implanted with the Senseonics’ Eversense implantable continuous glucose monitoring (CGM) system can leave the device in place during MRIs.

The system is comprised of a fluorescence-based sensor, a transmitter worn over the sensor to enable data communication and a mobile app that displays glucose values, alerts and trends. It can be removed, recharged and re-adhered without throwing out the sensor.

The CGM sensor is implanted subcutaneously in a patient’s upper arm by a health care provider during a short in-office procedure.

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