The FDA approved Senseonics' continuous glucose monitoring system for adults with diabetes June 21.
The device, the Eversense CGM system, marks the first FDA-approved CGM system that includes a fully implantable sensor to detect glucose. To use the Eversense CGM system, a patient must visit a healthcare provider for an outpatient procedure, during which the provider will implant a small sensor just under the patient's skin.
The sensor, which can stay implanted for up to 90 days, regularly measures a patient's glucose levels and delivers the information to an associated app on their tablet or smartphone every five minutes.
The FDA held an advisory committee meeting to assess the safety and effectiveness of the Eversense CGM system prior to approval, during which the committee reviewed clinical studies involving 125 adult diabetes patients. The committee voted 8-0 that the benefits of the system outweighed potential risks.
The clinical studies reviewed by the advisory committee found less than 1 percent of patients experienced a series adverse event associated with the implanted sensor. The FDA will continue to evaluate the safety of the CGM system in a post-approval study.
In a June 21 statement on the approval, FDA Commissioner Scott Gottlieb, MD, highlighted the agency's digital health software pre-certification pilot program, which aims to streamline the regulatory process for software products, including mobile apps.
"The FDA is committed to advancing novel products that leverage digital technology to improve patient care," Dr. Gottlieb said. "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."