The line between a medical device and a health-focused wearable is about to get much blurrier. Over the past year, Apple met with the Food and Drug Administration to ensure that its first wearable doesn’t face tough government regulation. Based on the FDA’s most recent guidelines for wearable regulation, it seems the company has succeeded. However, many health-focused companies are working on apps that are intended to help people with chronic health issues stay on top of their well-being.
The most recent Apple Watch app to come out of the woodwork isn’t from Uber or Tesla, it’s from a medical device maker named DexCom. DexCom has created a continuous glucose monitoring device that can be incorporated into the Apple Watch and linked up with an app on the device, reports the Wall Street Journal. DexCom’s monitor places a sensor that’s as wide as a human hair under the skin to measure glucose every five minutes. The company’s app then converts all the data collected by the Apple Watch and DexCom’s sensor into a simple graph that illustrates blood sugar levels, so the wearer knows that they are in the safe range.
The app will be ready to go when the Apple Watch debuts in April, so long as it receives FDA approval. Luckily, getting a mobile app that registers data from a certified medical device through the FDA is relatively easy. The app simply needs to register with the FDA, and doesn’t need marketing approval ahead of time. DexCom’s glucose sensors are still Class III devices, but since those kinds of devices are the most heavily monitored by the FDA already, the company’s app will go through much less scrutiny before landing on the Apple Watch. The company already has iOS and Android apps that monitor glucose levels.
Seeing as 29 million Americans have diabetes, DexCom’s app could make the Apple Watch a must-have device for those with the most serious type of diabetes. If DexCom’s app is any indication, the Apple Watch may end having all the powers of a medical device, without having to jump through any of the hoops medical devices have to go through.
