FDA Approves First Receiver-Less CGM
The Dexcom G5 Mobile CGM gets the green light by the FDA to beam blood glucose readings directly to smartphones.
Dexcom has announced FDA approval for their newest continuous glucose monitor (CGM), the G5 Mobile, which sends glucose readings directly to a mobile device. The device marks the first time CGM users can officially ditch a separate receiver. It is also the first on the market to be approved for users as young as two years of age, perhaps because it doesn’t require a separate receiver, which would take up a lot of real estate on a two-year-old body.
Using wireless Bluetooth technology, the device can send readings and alert notifications directly to an iOS-enabled device, and that information can then be shared with up to five other devices. The G5 mobile app, currently set to premiere first in the Apple App Store, is free to download and features a glucose graph and trend detection feature. An Android-friendly app is expected to become available at the beginning of next year, according to a Dexcom press release.
This is apparently one of the rare instances when the FDA moved quicker than expected to greenlight a new device, according to Dexcom President and CEO Kevin Sayer. The company was caught slightly off guard by the pace of approval and is now quickly trying to gear up to launch the product by the end of September. Dexcom is offering customers a no-cost upgrade if they purchased the previous generation product, the G4 Platinum, during the month of August, 2015.
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