The announcement comes with word from FDA touting the effectiveness of its efforts to advance digital health regulatory pathways.
Apple today announced that FDA had cleared a new watch that can take an electrocardiogram (EKG), giving the consumer technology giant a long-sought footprint in the world of regulated medical devices. The unveiling of the Apple Watch Series 4, which includes new fitness, activity, and communications features, was accompanied by an FDA statement touting the agency’s efforts to spark digital health innovation.
The watch is a major upgrade from the original, which offered a basic heart monitor. A version offered in 2017 included a Heart Study app, which detected wearers who were at risk and connected them to a patch from a third-party company to perform a test called an electrogastrogram.
Apple Watch Series 4 lets customers take an EKG from the wrist using an app that engages electrodes in the watch’s digital crown and a heart rate sensor built into the device’s crystal. A user places a finger on the digital crown, sending a current across the chest to read electrical heart signals. It takes 30 seconds to read whether the user has a normal heart rhythm or shows signs of atrial fibrillation, a risk factor for stroke. Each recording is stored in the app and can be shared with a user’s physician. A separate app, which also received FDA clearance, evaluates pulse rate and can detect irregular heart rate rhythm.
Company officials also touted a feature that detects hard falls; the user can dismiss an alert or call emergency services. The watch can be set to automatically call emergency services with a user’s location after 60 seconds if it senses 60 seconds of immobility. A user’s emergency contacts would also be notified.
The FDA statement, from Commissioner Scott Gottlieb, MD, and Radiological Health Director Jeff Shuren, MD, JD, said the clearance of the mobile medical apps shows the effectiveness of the agency’s efforts to create regulatory tracts for companies not accustomed to navigating this landscape.
“The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly,” the statement said. “Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.”
In July 2017, Gottlieb published a blog post that outlined his goals for FDA’s handling of digital health technology, and FDA’s Center for Devices and Radiological Health released a Digital Heath Innovation Action Plan. The approach seeks to be more nimble and flexible to reduce time and cost of market entry. Both traditional medical device companies and consumer-focused entities like Apple were invited to apply for a software precertification pilot program to create regulatory paths for these products.
In general, the approach calls for regulating the company than each individual product, so that individual software patches or updates can be done seamlessly.
The Apple Watch Series 4 (GPS) starts at $399, and the GPS + Cellular version starts at $499, including the new health features.