US-based medical technology company Senseonics and its partner Ascensia Diabetes Care have secured the US Food and Drug Administration (FDA) approval for the Eversense 365 CGM system.
Ascensia Diabetes Care, a subsidiary of PHC Holdings, has been a strategic partner to Senseonics since 2020 and an exclusive distributor of its Eversense CGM systems.
Eversense 365 is a fully implantable continuous glucose monitoring (CGM) system, indicated for use in individuals with Type 1 and Type 2 diabetes, aged 18 years and above.
It is the world’s first and only one-year CGM system with a 365-day sensor, which represents a significant breakthrough in diabetes technology and management, said Senseonics.
Eversense 365 is also approved as an integrated continuous glucose monitoring (iCGM) system, authorising its use with compatible medical devices.
As an iCGM device, Eversense 365 can be integrated with compatible medical devices, including insulin pumps related to an automated insulin delivery (AID) system.
Senseonics and Ascensia Diabetes Care are currently in talks with insulin pump manufacturers.
Senseonics president and CEO Tim Goodnow said: “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.
“Eversense 365 was ‘designed for real life’ and is optimally suited to help people with diabetes increase time in a range of desired glucose levels and lower A1c.
“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.”
Senseonics said that the Eversense 365 eliminates frequent sensor changes, with only one insertion every year, compared to insertion every 10-14 days with short-term CGM systems.
It reduces the burden of data interruptions from frequent short-term CGM sensor failures.
The system comes with a tiny sensor that provides accuracy consistently for one year and almost no false alerts from compression lows during the night.
It is used with a silicone-based adhesive that can be changed daily, without any skin reactions.
Eversense 365 is said to be the only CGM system with a removable transmitter that can be easily worn and removed, without wasting a sensor or adding a warm-up period.
Furthermore, Ascensia Diabetes Care intends to start commercialising the Eversense 365 CGM system in the US, in the fourth quarter of this year.
Ascensia Diabetes Care CGM president 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 automated insulin delivery (AID) systems.”
