FDA clears first glucose-monitoring system for mobile devices
|The G4 Platinum CGM–Courtesy of Dexcom|
The FDA has cleared the first glucose-monitoring system designed to be used with smartphones and other devices that can remotely track the health of a diabetic and “share” the information with up to 5 additional “followers.”
Dexcom’s ($DXCM) G4 Platinum Continuous Glucose Monitoring System with Share uses a small, wirelike sensor inserted underneath the skin to transmit data by a secure wireless connection using Bluetooth Low Energy (BLE) technology. That information can then be remotely tracked by up to 5 designated recipients without the need for a dedicated docking cradle, the company said in a press release.
Those “followers” will be able to remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere on their iPhones, and other devices.
“It will provide a huge improvement for people managing their diabetes and for those parents and caregivers who help them each and every day,” Kevin Sayer, Dexcom’s president and CEO, said in a statement.
The San Diego-based company’s apps related to the new device were cleared last Friday. The system itself was cleared today under the regulatory agency’s de novo process, which was created for low- to moderate-risk devices and doesn’t require the same rigorous review as more complicated products.
Although there are similar devices that have been developed, Dexcom’s is the first to be given the regulatory green light for U.S. sales since the FDA began regulating mobile medical applications as devices in 2013. According to the regulatory agency, there are an estimated 25.8 million people in the U.S. with diabetes, and about 215,000 of them are under the age of 20.
This is the first Dexcom system that is mobile compatible without the use of a docking system and is expected to be available by March, the company said.
Dexcom is up 6% in early trading.
Editor’s note: This story was updated to clarify the regulatory process involved.
– see Dexcom’s release
– check out the FDA release
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