Senseonics Gets Green Light from FDA on Implantable Glucose Monitoring System
Senseonics recently received Premarket Approval from the Food and Drug Administration (FDA) for its Eversense® Continuous Glucose Monitoring (CGM) System. According to Senseonics, the Eversense® CGM System is the first and only implantable device to allow for continuous blood-glucose monitoring for as long as three months.
The Eversense ® CGM system includes an implantable glucose sensor, a wearable transmitter, and the Eversense Mobile App. Senseonics advertises the sensor as utilizing fluorescent, glucose indicating polymer technology to measure glucose in the interstitial fluid. According to Senseonics, measurements from the sensor are conveyed to the wearable transmitter, which wirelessly communicates with the Eversense Mobile App to display real-time glucose measurements, trends, and alerts.
Commenting on the FDA approval, Senseonics President and CEO Tim Goodnow stated:
“With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way.”