First Continuous Glucose Monitoring System with Fully Implantable Sensor Gains FDA Approval

Senseonics was granted FDA approval for the Eversense Continuous Glucose Monitoring (CGM) system’s use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.

“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” said FDA Commissioner Scott Gottlieb, MD, in a 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 Eversense CGM system utilizes a small sensor—implanted just under the skin by a qualified health care provider during an outpatient procedure—to regularly measures glucose levels in adults with diabetes for up to 90 days. The implanted sensor works with a novel light-based technology to measure glucose levels, and sends information to a mobile app to alert users if glucose levels are too high or too low. The sensor is coated with a fluorescent chemical which, when exposed to blood sugar, produces a small amount of light that is measured by the sensor. Every 5 minutes, measurements are sent to a compatible mobile device that is running a device-specific mobile app.

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