With this designation, Eversense becomes the first fully implantable device in the category. Senseonics can now market the long-term CGM through the FDA’s de novo pathway. This establishes the special controls serving as a predicate device for future 510(k) submissions.
iCGM status indicates that Eversense can integrate with compatible medical devices. That includes insulin pumps as part of an automated insulin delivery system. Senseonics and Ascensia Diabetes Care, its distribution partner, plan to advance partnership discussions with pump manufacturers.
According to Senseonics, Eversense is “exceptionally well-suited” for automated insulin delivery systems.
Eversense, the longest-lasting CGM available, offers six months of wear time and only one insertion. It offers accuracy in critical low glucose ranges and essentially no compression lows. The system also has alert detection to support accurate corrections in real time. Eversense also has a removable transmitter that can be taken off without wasting a sensor or adding a warm-up period.
“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, 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.”
The analyst’s view on the Senseonics news
BTIG analysts Marie Thibault and Sam Eiber view the news as positive for Senseonics’ pipeline. They also say the company plans on submitting its application for the 365-day version following this iCGM designation.
“We believe that having the iCGM designation, alongside a longer-duration sensor, will make Eversense more appealing to the larger segment of the population due to its broader integration potential,” the analysts say. “However, we have yet to see consistent adoption of Eversense.”
The analysts remain “Neutral” on Senseonics.
