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Eversense CGM System receives iCGM designation by FDA

Senseonics Holdings, Inc. announced that Eversense® has been granted an integrated CGM (iCGM) designation by the US Food and Drug Administration (FDA).

As the first fully implantable device in the category, Eversense has been authorized to be marketed as an iCGM through the FDA’s De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future for devices of the same type.

iCGM status indicates that Senseonics’ Eversense iCGM product can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system. The companies plan to advance partnership discussions with various pump manufacturers, with plans to offer people who choose to integrate their diabetes devices a new interoperable CGM option that is exceptionally well suited for AID systems. This is because Eversense addresses common limitations of AID systems outlined in the 2022 Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association.

“Managing diabetes is all about personal choice and finding the options that best support an individual to live a healthier, less interrupted life,” said Brian Hansen, President of CGM at Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “For many, one of these choices is to take some of the calculation out of diabetes management by integrating their CGM with an insulin pump as part of an AID system. We are pleased that Eversense has been granted iCGM designation by the FDA, so that people who desire this integration in the future will be able to choose Eversense and access its unique benefits.”

“The iCGM designation has been a core component of our strategic initiatives to advance our pipeline, and we are excited to move forward with the next steps to accelerate integration of the world’s longest lasting CGM with leading insulin devices,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “The rigorous data requirements for this FDA designation highlight our team’s advanced engineering expertise in developing a CGM that meets high standards. Our confidence in our differentiated technology is high, as there is a tremendous opportunity with iCGM to deliver value and provide substantial benefits to diabetes patients. As we look ahead, we are focused on progressing our partnership discussions and software developments, and look forward to providing more updates.”

Designed by Senseonics and brought to people with diabetes by Ascensia, the Eversense CGM System offers a fully implantable option that is exceptionally well suited for AID therapy:

  • The longest lasting CGM available with 6 months of wear time and only one insertion and one “Day 1”
  • Most accurate CGM in critical low glucose ranges with essentially no compression lows
  • Most dependable CGM alert detection to support accurate corrections in real time
  • The only CGM with a removable transmitter which can be taken on and off without wasting a sensor or adding a warm up period

MB Bureau

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