Dexcom's Apple Watch app will be ready to go when the device launches in April, the company . The app, which will not need to seek pre-market approval from the FDA thanks to a recent reclassification, will allow the Apple Watch to serve as a secondary display device for the Dexcom G4 (and upcoming G5) continuous glucose monitor system. The primary display will remain on a dedicated receiver device.
Dexcom demoed an Apple Watch app for reading CGM data at CES this year. The app interface at the demo looked similar to the Dexcom Share app, the company’s FDA-cleared app that syncs with a hub to collect glucose readings. And data sent to the Apple Watch would also be available via Apple’s HealthKit platform so that other health apps and devices can use the data, the company said at the time.
Then, in January, the company received FDA approval for a new receiver that would eliminate the docking cradle and allow a patient’s continuous glucose monitor data to be transferred directly to a user’s smartphone, as well as the smartphones of up to five friends or caretakers. It also received approval for two smartphone apps, one for the user and one for friends or caretakers.
The receiver went through a Class III pre-market approval process, but the apps, which will display the CGM data, were approved through a de novo classification process and then down-classified to a Class II device exempt from premarket clearances. That means future applications that display CGM data — while not claiming to be the primary readout of that data — will be able to get through the FDA just by registering. That goes for a potential Dexcom Apple Watch app, too.
On an investor call, Dexcom CEO Kevin Sayer said that in addition to the two iOS apps already available, versions of these apps for Android would be coming soon and would be able to skip the FDA’s pre-approval process because of the down classification. At the time Sayer said the Android app and smartwatch apps would be launched “over the course of the year” though the company hadn’t locked down a time frame.
Eventually, the company also plans to expand to apps that wouldn’t be covered by the down classification: apps that analyze the CGM data, possibly for clinical decision support. Sayer admitted as much in the call, but stressed that these are longterm plans.
“In the near term, we’ll focus on CGM data presentation,” he said. “Certainly over time we will have broader apps that include more. We want to have pump information and other diabetes information. But we haven’t laid out a pipeline for that, we’re still developing our tools. You’ll hear more in the future.”
The WSJ report also points out that the Dexcom case proved out how the FDA can be a throttle point for innovations that consumers desperately want. While Dexcom's Share platform was still seeking regulatory approval, a group of software engineers developed an open-source, DIY system for sharing CGM results over the internet, . Because it was being given away for free and not sold, it bypassed the FDA and spread to thousands of users via social media. Incidentally, NightScout users have already been able to display their CGM data on the Pebble smartwatch.