FDA Designates Eversense CGM as iCGM

Senseonics and Ascensia Diabetes Care have announced that their product, Eversense, has received the integrated CGM (iCGM) designation from the US Food and Drug Administration (FDA). This approval allows Eversense to be marketed as an iCGM through the FDA’s De Novo pathway, setting special controls that will act as a benchmark for future 510(k) submissions for similar devices.

The iCGM designation means that the Eversense iCGM can integrate with other medical devices, such as insulin pumps, to form an automated insulin delivery (AID) system. The partnership between Senseonics and Ascensia aims to collaborate with various pump manufacturers to provide an interoperable CGM option suitable for AID systems. Eversense is designed to overcome common limitations of AID systems, as highlighted in the 2022 Consensus Report by the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association.

Brian Hansen, president of CGM at Ascensia Diabetes Care, emphasized the importance of personal choice in managing diabetes. He stated, "Managing diabetes is all about personal choice and finding the options that best support an individual to live a healthier, less interrupted life. 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."

Tim Goodnow, PhD, president and CEO of Senseonics, expressed excitement about the iCGM designation, stating that it has been a crucial part of their strategy to advance their product pipeline. "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," he said. Goodnow also highlighted the rigorous data requirements for the FDA designation, which demonstrate the advanced engineering expertise of their team. He added, "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."

The approval of Eversense as an iCGM is significant for the diabetes community, offering a new option for integrating CGMs with insulin pumps. This integration is expected to simplify diabetes management for patients, allowing for more personalized and efficient care. The collaboration between Senseonics and Ascensia Diabetes Care aims to bring innovative solutions to the market, enhancing the quality of life for people with diabetes. As the companies move forward with their plans, they are committed to advancing their technology and strengthening their partnerships to deliver the best possible outcomes for diabetes patients.