Dexcom ($DXCM), which was the first devicemaker to get FDA clearance for a glucose-monitoring system for mobile devices, is looking to notch another first by designing a similar app for Apple's ($AAPL) smartwatch that is expected to launch in April.
The Dexcom app converts data from its glucose monitor that continuously tracks blood-sugar levels into a graph that will be displayed on the screen of the smartwatch. The company said it expects the app to be ready for the Apple Watch when sales begin in less than two months, The Wall Street Journal reported.
Although Apple--which declined to comment for the WSJ story--hasn't given a formal OK to any apps for its much-anticipated smartwatch, the company has provided guidelines and code to developers working on apps for the device.
San Diego-based Dexcom's early lead in what is a crowded and competitive field has been helped by recent loosening of oversight over mobile apps by the regulatory agency.
"We will still be expected to perform all procedures required by the FDA to document, validate, and verify our software apps as with any third-party which needs to provide secondary display of our CGM data," Kevin Sayer, the company's chief executive, recently said during an earnings call. "But there will be no more review time at the FDA. This change will enable us to move more quickly on secondary display developments for things like the Apple Watch and Android apps."
|The G4 Platinum CGM--Courtesy of Dexcom|
Late last month, the agency cleared Dexcom's G4 Platinum Continuous Glucose Monitoring System with Share, which uses a small, wirelike sensor inserted underneath the skin to transmit data by a secure wireless connection using Bluetooth Low Energy technology. That information can then be remotely tracked by up to 5 designated recipients without the need for a dedicated docking cradle.
Despite the development of similar devices by competitors, Dexcom was the first to get the FDA's go-ahead to begin U.S. sales since the agency began regulating mobile medical applications as devices in 2013. It's estimated there are about 25.8 million people in the U.S. with diabetes, and about 215,000 of them are under the age of 20.
- check out the WSJ story (sub. req.)
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