FDA

FDA Allows Marketing of First Interoperable Continuous Glucose Monitoring System

By MedTech Intelligence Staff
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FDA

About the size of a quarter, the patch transmits real-time glucose readings every five minutes.

FDA announced that it is allowing Dexcom to market its G6 integrated continuous glucose monitoring system (iCGM). It is the first fully interoperable iCGM and can be used to determine the blood glucose levels in children ages two and older and adults with diabetes.

“This is the first type of continuous glucose monitoring system permitted by the agency to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management,” FDA stated in a news release. “Today’s authorization also classifies this new type of device in class II and subjects it to certain criteria called special controls. This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible.”

The device is a quarter-sized patch that is applied to the abdomen. A sensor continuously measures glucose in body fluid and transmits the real-time readings every five minutes. If the patient’s sugar enters a dangerous zone, an alarm is triggered. The patch, which should be replaced every 10 days, can also be integrated with an automated insulin dosing system.

 

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