After collecting FDA green lights for 90- and 180-day versions, the agency has cleared the latest generation of the Eversense continuous glucose monitoring system that only needs to be swapped out once per year.
Developed by Senseonics and Ascensia Diabetes Care, the Eversense 365 implant got the go-ahead for adults with Type 1 or Type 2 diabetes. It includes a sensor about the size of a grain of rice that is placed underneath the skin, which sends blood sugar readings to a wearable transmitter placed over the top.
“The delivery of the world’s first 365-day sensor is a seminal event for Senseonics and we’re excited to bring it to people with diabetes,” President and CEO Tim Goodnow said in a statement.
The Eversense 365 was also cleared by the FDA as an integrated CGM system, allowing it to connect to compatible insulin pumps and other pieces of diabetes hardware. Ascensia said it plans to begin the sensor’s commercial launch in the fourth quarter of this year, as it works to secure reimbursement coverage.
“In parallel, our partnership discussions with various pump manufacturers continue to progress, as we look to leverage Eversense 365’s unique potential to simplify life with integrated automated insulin delivery (AID) systems,” said Brian Hansen, president of CGM at Ascensia.
The companies said that after the sensor’s insertion, it needs only one “Day 1” calibration period, compared to the repeated procedures required with sensors that have shorter wear times. In addition, the wearable transmitter can be removed without dislodging the sensor, with a silicone-based adhesive that can be changed daily.