Eversense CGM Granted iCGM Status from the FDA

Senseonics and Ascensia Diabetes Care revealed that the Eversense implantable continuous glucose monitor (CGM) has been granted an integrated CGM (iCGM) designation by the U.S. Food and Drug Administration (FDA).
 
Eversense is the first fully implantable device in the category. It was authorized to be marketed as an iCGM through the De Novo pathway by establishing the controls that will serve as a predicate device for 510(k) submissions in the future, for the same type of devices.
 
iCGM status means Eversense can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system. The companies said they plan to have partnership discussions with pump manufacturers, with plans to offer people who integrate their diabetes devices a new, interoperable CGM option that’s well suited for AID systems.
 
“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. “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.”
 
With a six-month wear time, Eversense is the longest-lasting CGM available, according to the companies. It only has one insertion and one “Day 1” as well.
 
The company said based on several studies that Eversense is the most accurate in critical low glucose ranges with essentially no compression lows. It has the most dependable CGM alert detection, to support accurate corrections in real-time, and is the only CGM with a removable transmitter that can be taken on and off without wasting a sensor or adding a warmup period. (However, there’s no glucose data generated when the transmitter is removed.)
 
“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, Ph.D., president and CEO 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.”