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FDA Approves Implantable Glucose Sensor Device

FDA Web site; 2018 Jun 21

The US Food and Drug Administration (FDA) has approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people aged ≥18 years 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 granted approval of the Eversense Continuous Glucose Monitoring System to Senseonics Holdings, Inc., headquartered in Germantown, MD.

Indications: The Eversense CGM system uses a small sensor that is implanted just under the skin by a qualified health care provider during an outpatient procedure. After it is implanted, the sensor 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 send information to a mobile app to alert users if glucose levels are too high (hyperglycemia) or too low (hypoglycemia). 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 (eg, smart phone or tablet) that is running a device-specific mobile app.

Adverse effects: Potential adverse effects related to insertion, removal and wear of the sensor include allergic reaction to adhesives, bleeding, bruising, infection, pain or discomfort, scarring or skin discoloration, sensor fracture during removal, skin inflammation, thinning, and discoloration or redness.

Citation:

FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes. [news release]. Germantown, MD: Senseonics Holdings, Inc. June 21, 2018.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611454.htm?utm_campaign=06212018_PR_FDA%20approves%20first%20CGM%20with%20a%20fully%20implantable%20glucose%20sensor&utm_medium=email&utm_source=Eloqua. Accessed June 22, 2018.

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