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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

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