The launch comes a few months after the company picked up CE mark for the long-term, implantable CGM in January. The year-long sensor rests under the skin, meaning it can not be knocked off, minimizing inconveniences and replacement costs. In terms of comfort, users can change its gentle, silicone-based adhesive daily with almost no skin reactions.
Eversense 365 is the world’s first 365-day CGM system. It also holds clearance as an integrated CGM (iCGM) system, meaning it can work with compatible medical devices. Those include insulin pumps as part of automated insulin delivery systems, like the Sequel Med Tech twiist system.
Germantown, Maryland-based Senseonics received FDA clearance for Eversense 365 in September 2024. It launched the year-long CGM implant with its global distribution partner, Ascensia Diabetes Care, the following month. It has since taken over full commercial activity for the technology.
The company said it made Eversense 365 available to the first patients in Sweden. It plans to bring the sensor to Germany, Spain and Italy in the coming weeks as well.
Learn more about Eversense 365 from an interview with Senseonics VP of Product Development Hari Sree in a recent Medical Design & Outsourcing interview.
Commentary from Senseonics officials
Tim Goodnow, president and CEO of Senseonics, said:
“This launch of Eversense 365 is a significant breakthrough for diabetes technology in Europe and for Senseonics as a business, as we successfully transition to an end-to-end commercial organization this year. Building on demonstrable commercial momentum in the U.S., European expansion is a key part of our Eversense 365 growth strategy, increasing our total addressable market by over 30 million patients.”
Brian Hansen, chief commercial officer of Senseonics, said:
“The excitement for Eversense 365 was palpable at ATTD and we’re thrilled to now offer this life-changing technology to the first patients in Europe. Real-world evidence showcases Eversense 365’s unique benefits – delivering one year of exceptionally accurate monitoring with minimal interruptions – enabling patients to focus on managing their diabetes and not their CGM.”
