Eversense 365 Receives FDA Clearance
The World’s First One Year CGM
Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes and Ascensia Diabetes Care, a global diabetes care company, today announced that the US Food and Drug Administration (FDA) has cleared the next-generation Eversense 365 CGM system for people with Type 1 and Type 2 diabetes aged 18 years and older. Eversense 365 is the world’s first One Year CGM system, representing a significant breakthrough in diabetes technology and management.
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The Eversense 365 CGM system is supporting people with diabetes to live life uninterrupted, as a fully-implantable, long-term CGM option that is highly-differentiated from short-term CGMs (Photo: Business Wire)
“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,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “Eversense 365 was ‘designed for real life’ and is optimally suited to help people with diabetes increase time in 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.”
“Managing diabetes can be stressful and it is important for technology to disrupt life as little as possible to limit this burden,” said Brian Hansen, President of CGM at Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “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.”