Eversense continuous glucose monitoring systemSeptember 14, 2018
Senseonics Holdings, Inc received premarket approval for Eversense Continuous Glucose Monitoring (CGM) System to target people with diabetes in the United States.
The CGM system features an implantable glucose sensor and provide long-term continuous monitoring for up to three months.
The Eversense 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 system’s smart transmitter interprets glucose data from the sensor and sends it to the system’s mobile application via Bluetooth. It also provides on-body vibratory alerts for discretion and added safety. The transmitter can be removed and recharged without discarding the sensor.
The Eversense application was based on the previously-reported results of the PRECISE II U.S. pivotal trial in which Eversense was studied in 90 adults with type 1 or type 2 diabetes at eight clinical centres in the US to demonstrate the system’s safety and effectiveness over 90 days of continuous wear.