Senseonics Wins Nod for Implantable Long-Term CGM

Senseonics Holdings said it has received a PMA for the Eversense Continous Glucose Monitoring (CGM) system. The Germantown, Md-based company said the system is the first and only CGM to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months. “We’re very pleased to receive this FDA approval that allows us to make Eversense available in the U.S., as it is in many European markets,” Tim Goodnow President and CEO of Senseonics said in a release. “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. More importantly, we believe the unique features Eversense offers will help open up CGM to millions of people with diabetes who, up to this point, have been hesitant to try CGM despite the clear health benefits it provides.” The Eversense System addresses many of the barriers to CGM use. The 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, which is inserted subcutaneously in the upper arm by a physician via a brief in-office procedure, lasts up to three months, thereby eliminating the need for patients to self-administer the weekly or biweekly sensor insertions required by traditional CGM systems. The ...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news