The FDA just announced that they have granted approval of Senseonics Holdings, Inc.’s Eversense Continuous Glucose Monitoring (CGM) system, the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days. It is for use in people 18 years of age and older with diabetes in the U.S.
“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” commented FDA Commissioner Scott Gottlieb, M.D. in a press statement. “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”.
The FDA evaluated clinical study data from 125 individuals aged 18 and older with diabetes and found that a serious adverse event with the implanted sensor was experienced by less than 1 percent. The safety of the new system will be again evaluated in a post-approval study. In the FDA’s Advisory Committee meeting, the independent committee In an 8 to 0 vote recommended that the benefits of the Eversense CGM system outweigh the risks for patients with diabetes.
There are a range of adverse side effects associated with insertion, removal and wear of the sensor. Other risks associated with use of the CGM system may include hypoglycemia or hyperglycemia I that may occur when information provided by the device is inaccurate or when alerts are missed.
“We believe the unique features Eversense offers will help open up CGM to millions of people with diabetes who, up to this point, have been hesitant to try CGM despite the clear health benefits it provides,” said Tim Goodnow, President and CEO of Senseonics in a separate press statement.
The FDA indicated in their announcement that it is advancing to provide “a new and more carefully tailored regulatory approach for software products, including mobile medical apps that will enable efficient oversight of these digital technologies and maintain FDA’s gold standard for product review”.
