Medical technology companies Senseonics and Ascensia Diabetes Care have announced receipt of the US Food and Drug Administration (FDA) approval for the Eversense 365 continuous glucose monitoring (CGM) system for individuals aged 18 and over with type I and type II diabetes.
Eversense 365 is claimed to be the world's first one-year CGM system, offering a new long-term solution for diabetes management.
Eversense 365 is designed to support people with diabetes in leading an uninterrupted life, distinguishing itself from short-term CGMs through its fully-implantable, 365-day sensor, unlike the 10-14 day sensor changes required in short-term systems.
The long-lasting sensor aims to reduce the burden of data interruptions from frequent sensor failures or changes.
The system also addresses the issue of wasted sensors, as its tiny, under-the-skin sensor cannot be easily dislodged, reducing the inconvenience and cost of regular replacements.
Eversense 365 boasts accuracy for an entire year and minimises false alerts from compression lows during sleep. Its gentle silicone-based adhesive, which can be changed daily, is designed for maximum comfort and minimal skin reactions.
It enhances user freedom with a removable transmitter that can be taken on and off without wasting a sensor or necessitating a warm-up period. The system also offers improved discretion with on-body vibration alerts to keep patients notified even when their mobile phone is not within sight.
Senseonics president and CEO Dr Tim Goodnow said: “The approval of Eversense 365 represents a significant leap in CGM innovation.
“Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes.”
The FDA's clearance of Eversense 365 as an integrated CGM (iCGM) system allows for integration with compatible medical devices, including insulin pumps for automated insulin delivery (AID) systems.
The system is claimed to be particularly well-suited to address common limitations associated with AID systems, and partnership discussions with various pump manufacturers are progressing.
Ascensia expects to launch Eversense 365 in the US in the fourth quarter of 2024 and is working to transition coverage availability to ensure immediate access for as many users as possible.
PHC Holdings’ subsidiary Ascensia Diabetes Care president of CGM Brian Hansen said: “Eversense 365 allows people with diabetes to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs. We are very excited about Senseonics’ ability to once again bring true innovation to the CGM space and are working closely with our partner to make Eversense 365 commercially available as soon as possible.
“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 AID systems.”
In May, Senseonics, in collaboration with Ascensia Diabetes Care, announced receipt of an integrated continuous glucose monitoring designation from the FDA for its Eversense product.
