Senseonics wins MRI-safe FDA nod for Eversense CGM

Senseonics announced that it has received notice from the FDA that its Eversense sensor no longer has to be removed for MRI scanning.

“Based on our testing, we have demonstrated hat it is safe for patients to leave the Eversense Sensor in place, even when they need to have an MRI,” Tim Goodnow, president and CEO of Senseonics, said in a press release. “Now patients using Eversense CGM do not need to worry about an emergency MRI or delay getting a scheduled MRI based on their glucose sensor. All other CGMs currently on the market are required to be removed before an MRI scan, according to their FDA indications. This is a first for the CGM category.”

Patients who have the sensor are now able to be safely scanned in an MRI with static magnetic field of 1.5T or 3.0T, maximum spatial field gradient of 2000 gauss/cm or maximum MR system with whole body averaged specific absorption rate of 4 W/kg.

The Eversense CGM System uses a fluorescence-based sensor, a smart transmitter worn over the sensor for data communication and a mobile app to display glucose levels, trends and alerts. It also features a smart transmitter that gives users a discreet on-body vibration alert for low and high glucose levels. The transmitter can be removed, recharged and re-adhered without throwing the sensor away. Senseonics’s Eversense is inserted subcutaneously in the upper arm by a doctor in an in-office procedure.