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.
Now, our sister site, Drug Delivery Business News, reports today that the company can bring the system to Europe, earning CE mark in compliance with the EU Medical Device Regulation (MDR). This comes on the heels of the launch of Eversense 365 with Sequel Med Tech’s twiist pump, marking the first pump integration for the CGM.
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 twiist.
Market-leading, non-implanted CGMs like Abbott’s and Dexcom’s have wear times around two weeks. For Eversense 365 users, this means no frequent sensor changes and only one insertion and one “Day 1” every year.
Get the full story at our sister site, Drug Delivery Business News.
