Senseonics Seeks the CE Mark Approval for Eversense 365 System
Shots:
- Senseonics has filed for the CE Mark Approval of its Eversense 365 CGM system. If approved, it will be distributed in the EU (Germany, Italy, Spain, Poland, Switzerland, Sweden, & Andorra) by Ascensia Diabetes Care (Senseonics' commercial partner)
- Eversense offers longevity (1yr. vs 10-14 days for traditional CGMs), features a removable smart transmitter to reduce wastage, offers max. comfort with silicone adhesives, & requires 1 calibration/wk. to provide reliable alerts with high accuracy
- In Sep 2024, the US FDA granted 510(k) clearance to Eversense as an iCGM system, allowing its integration with compatible medical devices incl. insulin pumps as a part of automated insulin delivery (AID) system to address its limitations
Ref: Senseonics | Image: Senseonics
Related News:- Gyder Surgical Reports the US FDA’s 510(k) Clearance for Gyder Hip System
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
