Apple seeking FDA approval for its Heart Study app
The app, which launched in November, uses the Apple Watch to calculate heart rhythm and notify someone who might be experiencing atrial fibrillation.
Abrar Al-HeetiTechnology Reporter
Abrar Al-Heeti is a technology reporter for CNET, with an interest in phones, streaming, internet trends, entertainment, pop culture and digital accessibility. She's also worked for CNET's video, culture and news teams. She graduated with bachelor's and master's degrees in journalism from the University of Illinois at Urbana-Champaign. Though Illinois is home, she now loves San Francisco -- steep inclines and all.
ExpertiseAbrar has spent her career at CNET analyzing tech trends while also writing news, reviews and commentaries across mobile, streaming and online culture.Credentials
Named a Tech Media Trailblazer by the Consumer Technology Association in 2019, a winner of SPJ NorCal's Excellence in Journalism Awards in 2022 and has three times been a finalist in the LA Press Club's National Arts & Entertainment Journalism Awards.
Consent documents sent to
Heart Study participants stated that collected data "will be used for FDA submission to seek approval of the investigational device." CNET has confirmed the device being referenced is the Heart Study app. If approved, this would be Apple's first FDA-cleared product.
Apple's Heart Study, a partnership with Stanford Medicine that launched in November, examines how the
heart rate sensor can be used to detect atrial fibrillation. The accompanying app could be a promising tool for detecting something that doesn't always show symptoms. Atrial fibrillation leads to approximately 750,000 hospitalizations and 130,000 yearly deaths in the US, according to the Centers for Disease Control and Prevention.
Apple has increasingly dabbled in health care, launching its ResearchKit software framework in 2015 for researchers to conduct studies through available apps. In 2016, it also launched CareKit, another open source framework where people can develop health apps. Both platforms have been used by more than 500 researchers and over 3 million participants, Apple says.
Apple was also among eight other companies, including Samsung and Fitbit, selected for the FDA's precertification pilot program, designed for companies that want to speed up the clearance process for future medical devices. By expediting a traditionally slow-moving process, the program could bring digital health innovations to market more quickly.
The Smartest Stuff: Innovators are thinking up new ways to make you, and the things around you, smarter.
Tech Enabled: CNET chronicles tech's role in providing new kinds of accessibility.