The US Food and Drug Administration (FDA) has approved Senseonics Holdings’ Premarket Approval (PMA) application to market its Eversense Continuous Glucose Monitoring (CGM) System.
The system, designed for diabetic patients, features an implantable glucose sensor and can offer continuous monitoring for up to three months.
Senseonics president and CEO Tim Goodnow said: “We’re very pleased to receive this FDA approval that allows us to make Eversense available in the US, as it is in many European markets.
“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.”
Eversense CGM comes with a fluorescence-based sensor and a smart transmitter fitted over the sensor to enable data transmission. It passes the data to a dedicated mobile app to display glucose values, trends and alerts.
The sensor needs to be inserted subcutaneously in the upper arm of the patient through an in-office procedure.
It can provide monitoring services for up to three months, significantly higher than the conventional CGM systems that need to be changed weekly or biweekly.
Furthermore, the system’s smart transmitter is said to be light and comfortable to wear.
It interprets glucose data from the sensor and transmits it to the mobile application through Bluetooth. It can also provide on-body vibratory alerts to the patients for additional safety.
The transmitter can be recharged or replaced separately without removing the sensor.