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FDA allows marketing of first CGM real-time data-sharing app system

Wednesday, January 28 2015 | Comments
Evidence Grade 0 What's This?
On Jan. 23, the Food and Drug Administration allowed Dexcom Inc. to market the company's Share Direct Secondary Displays, the first set of mobile medical apps for real-time sharing of data generated from a continuous glucose monitor (CGM). For now, the apps run on Apple mobile devices only, but Dexcom is planning on making them available for use on Android devices in the future.

The technology allows for remote monitoring of a patient's blood glucose levels, in this case a patient using the Dexcom G4 Platinum CGM System, via a secure wireless connection. Dexcom Share comprises 2 apps--one installed on the patient's mobile device and another on a "follower's" device. Followers are designated by the patient and are able to download real live data generated by the G4 CGM system. Data can be transmitted to as many as 5 designated recipients without the need for a dedicated docking cradle, according to Dexcom.

The FDA reviewed data for the Dexcom Share system through the de novo classification process, which is reserved for novel, low- to moderate-risk medical devices that have no equivalent already on the market. The system is classified as a class II device exempt from premarket submissions. Future similar devices by other manufacturers can therefore be marketed without having to obtain FDA premarket clearance first, though they will still need to be registered and listed with the FDA.

The Dexcom Share system is not intended to replace real-time continuous glucose monitoring/standard home blood glucose monitoring or a patient's primary display device. Of note, the FDA specified that CGM values by themselves are not approved to determine medication dosing--use of a glucose meter is required, and CGMs need to be calibrated by blood glucose meters.

Dexcom said the Share receiver is expected to ship to new patients in early March.

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