FDA Approves First CGM System Without Receiver

According to a news release by the company Dexcom, the US Food and Drug Administration has granted approval for the first continuous glucose monitoring (CGM) system which sends data directly to a smartphone without the need for a separate receiver.

Dexcom, recently in the news following their partnership with Google, becomes the first company to receive FDA device approval for their G5 Mobile CGM System, for use by adults and children as young as two. The G5 uses wireless Bluetooth technology that has been built into the transmitter and sends real-time glucose information directly to an app on iOS-enabled devices.

Dexcom says the device will be available for Android applications early in 2016.

Like the previous generation G4, the G5 allows for up to five followers, such as parents or other caregivers, to remotely monitor the patient's glucose levels and receive notifications regarding any readings that may cause concern.

The G5 system provides glucose trend information and issues alerts; however, fingerstick blood glucose testing has not been eliminated. It is still a requirement in order to determine insulin doses and to calibrate the system.

Source: Dexcom

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