Fully-implantable CGM receives FDA authorization for integration with insulin pumps
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Key takeaways:
- The FDA granted marketing approval to allow the Eversense E3 CGM to be integrated with insulin delivery systems.
- According to a press release, Eversense is the first fully-implantable integrated CGM.
The FDA granted integrated continuous glucose monitoring designation to a fully-implantable CGM, according to a press release.
The Eversense E3 CGM (Senseonics Holdings and Ascensia Diabetes Care) received authorization to be marketed as an integrated CGM through the FDA's De Novo pathway. The device is the first fully-implantable option in the category, according to the press release. The FDA authorization establishes special controls that serve as a predicate device for 510(k) submissions for future implantable devices.
The Eversense CGM consists of a small sensor that is inserted completely under the skin. The sensor communicates with a smart transmitter worn over the sensor. Data are uploaded every 5 minutes to a mobile app on the user's smartphone. The CGM is indicated for use for up to 180 days among adults aged 18 years and older with diabetes.
As Healio previously reported, the FDA originally approved the Eversense CGM for use among adults with diabetes in June 2018. A nonadjunctive indication was granted for the CGM to be used as a replacement for finger sticks to make diabetes treatment decisions throughout the day in June 2019. Use of the CGM was extended to 6 months by the FDA in February 2022.
Eversense's new marketing authorization will allow it to be integrated with compatible medical devices, including insulin pumps that are a part of an automated insulin delivery system. According to the press release, Senseonics plans to engage in partnership discussions with insulin pump manufacturers.
“The integrated CGM 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,” Tim Goodnow, PhD, president and CEO of Senseonics, said in a press release. “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 integrated CGM to deliver value and provide substantial benefits to diabetes patients.”
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