In a call to investors days after its app won FDA approval, Dexcom CEO Kevin Sayer shared some of the company's follow-up plans for its new smartphone-connected continuous glucose monitor, including Android and smartwatch apps and apps that will run some analytics on the CGM data.
Dexcom received the FDA approval just 120 days after filing, much more quickly than the company anticipated, leading to an investor call with many questions largely unanswered. Sayer promised a more complete update in the company's scheduled Q1 call.
When the new receiver first launches in early March, Sayer and EVP Steve Pacelli said on the call, two iOS apps will be available in the app store: the Share app, which receives and displays data from a nearby Dexcom CGM receiver, and the Follow app, which receives data remotely from a paired Share app.
Versions of these apps for Android will be coming soon, Sayer said, and will be able to skirt the FDA's pre-approval process because of the down classification. Sayer said the Android app and smartwatch apps would be launched "over the course of the year" though the company hasn'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."
Pacelli stressed that the FDA ruling is narrow. It will allow Dexcom and others to develop apps for new devices and platforms as they come out, such as, potentially, the Apple Watch. But it won't help if the company ever wants to create an app that eliminates the receiver entirely, for instance, and has the sensors send data directly to the phone.
"The primary display of CGM data will always remain a Class III medical device," he said. "Even if that is an app on a phone, if it talks directly to a transmitter, that is going to be a Class III medical device. That being said, a secondary display that isn’t the prime user has now been down-classed and we can move much more rapidly there. If [a third-party developer] can meet a patient need that we haven’t met and is compliant with all the rules and regulations, we would certainly consider working with them."
Sayer also stressed that once an app does anything with the data, including, especially, making recommendations to patients about actions, it would probably still need to be approved under the Class III process. Sayer was appreciative of the FDA's flexibility.
"Give the FDA credit," he said. "They put rules around this; they want to help us move faster. They see the technology moving rapidly and they want to give us guidelines to move with it. As you can imagine we’ve had many interactive conversations with them and will continue to do so."