The US Food and Drug Administration (FDA) has approved the use of Senseonics’ Eversense E3 continuous glucose monitoring (CGM) system for periods of up to six months.
The device uses sacrificial boronic acid (SBA) technology and is claimed to be the first and only long-term implantable CGM in the world.
The latest approval allows Eversense E3, which had previously been approved for a wear time of 90 days, to be used for up to six months.
Using a single sensor, the CGM system accurately tracks the glucose levels of users.
It includes a removable smart transmitter that is kept in place with a mild silicone-based adhesive.
The E3 transmitter provides glucose values, trends and discreet on-body vibratory alerts to a mobile app.
The CGM system offers a completely implantable third-generation sensor to patients, with SBA technology to improve longevity, that demonstrated an 8.5% mean absolute relative difference in the PROMISE Study.
Senseonics president and CEO Tim Goodnow said: “Further extending the duration of the longest-lasting CGM system to six months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community.
“The review was delayed by one year due to Covid-19 priorities and now together with our partner Ascensia, we can execute our launch plan to deliver the Eversense E3 CGM System to US patients beginning in the second quarter.”
The company stated that it plans to make the Eversense E3 CGM system available to patients in the US through its global commercial partner, Ascensia Diabetes Care.