The device is the first CGM system to feature an implantable sensor that can be worn for up to 90 days.
Senseonics’ Eversense device includes a small sensor that is implanted just below the skin in an outpatient procedure. It continuously measures glucose levels, sending that data to a mobile app every five minutes and alerting users if their glucose levels drop out of range.
In a 125-person study, researchers compared data collected by the Eversense CGM with data from a lab-based glucose analyzer. Senseonics reported that in clinical studies, the proportion of people that experienced a serious adverse event with the implanted device was less than 1%.
In March, an advisory committee for the FDA voted 8-0 to recommend that the agency approve Senseonics’ device.
“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” FDA chief Dr. Scott Gottlieb said in prepared remarks. “These technologies allow patients to gain better control over their health. This approval of a more seamless digital system that gives patients the ability to effectively manage a chronic disease like diabetes is a vivid illustration of the potential for these mobile platforms.”
“We’re very pleased to receive this FDA approval that allows us to make Eversense available in the United States, as it is in many European markets. With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way,” Senseonics president & CEO Tim Goodnow said in a press release.
SENS shares were trading at $5.12 apiece today in morning activity, up 3.6%.