Consent documents sent to Apple 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 Apple Watch's 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.
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