Senseonics Holdings has received a nod from FDA to make its Eversense Continuous Glucose Monitoring (CGM) system more accessible to patients. The agency’s approval allows qualified healthcare providers to be trained and certified to insert patients with Eversense, which lasts up to three months. Previously, the sensor insertion and removal procedure could only be performed by trained physicians.
“We are pleased with this FDA approval, we can now include nurse practitioners and physician assistants in the growing list of diabetes care professionals who can be certified to place the Eversense CGM System,” Tim Goodnow, president and CEO of Senseonics said in a release. “We believe that allowing additional health care providers to perform the in-office placement procedure for Eversense CGM will enable broader access to patients for this compelling long-term diabetes management technology.”
The Eversense CGM System consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. In addition, the system also features a smart transmitter that provides wearers with discreet on-body vibratory alerts for high and low glucose and that can be removed, recharged and re-adhered without discarding the sensor.
In June, the Germantown, MD-based company won a nod from FDA for the Eversense long-term CGM. The company said the system was the first and only CGM to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months. The device has been on the market in Europe for a little more than two years.