FDA Approval of Senseonics Eversense® CGM for Use for Up to 6 Months
Senseonics, a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, announced the approval of the next-generation Eversense® E3 CGM System by the Food and Drug Administration (FDA), for people ages 18+. The Eversense is the first and only long-term implantable CGM system, and the E3 includes technology that extends the use for up to 6 months.
JDRF funded Senseonics in 2000-2003, for a “Minimally Invasive Long-Term Implantable Flourescence Based Sensor for Continuous Monitoring of Glucose,” which later advanced into the Eversense technology. JDRF has spent years collaborating with the FDA to improve regulatory pathways for advanced diabetes technologies—and working closely with the Centers for Medicare and Medicaid Services (CMS) and commercial health plans to ensure this technology is covered and available to people with T1D.
Do you want to know what it’s like to use the Eversense?
Megan Casey, who has been working at JDRF for more than 15 years and using the Eversense since 2018, says: “I have tried several CGMs, and I feel like I have finally found the CGM that has been just perfect for me and my lifestyle.” She concluded: “I love my Eversense.”
You can also read about Kelli Raleigh, who was a former JDRF Outreach Manager, who shares her first-hand account of her experience on the Senseonics Promise Study. She says: “I think I’m most impressed with the idea that you never have to worry about your sensor ripping out or coming off like you do with other CGMs. Each day you change out the adhesive patch that the transmitter is stuck to and voila—that’s it! No pokes, needles, or anything needed.”
“The PROMISE study demonstrated safety and accuracy for the Eversense system for up to 180 days. JDRF believes strongly in user choice for diabetes treatments, and the FDA approval of this long-lasting implantable CGM, the first of its kind, is a great option for the T1D community,” says Jonathan Rosen, Ph.D., Associate Director, Research, JDRF. We congratulate the Senseonics team and thank the PROMISE study participants for contributing to this advance and the FDA for their diligence.”
The Eversense E3 is planned to be available to people in the United States beginning in the second quarter of 2022. People who are interested in getting started on Eversense today, can sign up here, and will be among the first to know when Eversense E3 is commercially available. Physicians, nurse practitioners, and physician assistants interested in offering the Eversense CGM System for their individuals can sign up here. Or contact 844-SENSE4U (844-736-7348) to learn more about the first and only long-term implantable CGM system.