Senseonics Holdings, Inc. announced that the FDA has approved the insertion and removal of its Eversense® Continuous Glucose Monitoring (CGM) System by qualified health care providers.
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,” said Tim Goodnow, president, and CEO of Senseonics in a company press 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,” he added.
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.
The sensor lasts up to three months.
In addition to featuring the first long-term and first implantable CGM sensor, the system is also first to feature a smart transmitter that provides users discreet alerts for high and low glucose. It can be removed, recharged and re-adhered without discarding the sensor.
The sensor can now be inserted subcutaneously in the upper arm by a physician, physician assistant or nurse practitioner during a brief in-office procedure.
Image courtesy: Senseonics.
Senseonics Announces FDA Approval to Expand Eversense® CGM Certification to Nurse Practitioners and Physician Assistants. Business Wire. 2018, November 6. Retrieved: https://www.businesswire.com/news/home/20181106006086/en.