The Apple Watch’s Atrial Fibrillation (AFib) History feature, which records and alerts users about heart-related events, has been recognized by the U.S. Food and Drug Administration (FDA) as part of its Medical Device Development Tools (MDDT) program.
According to Hamshahri Online, this marks the first program for digital health technology to be included. Since the Apple Watch provides estimated data on a user's AFib condition, it can now be used in clinical studies. The FDA announcement describes the device as a non-invasive method for collecting data before and after treatment.
Apple has long marketed its smartwatch as a life-saving device for its users. Features like fall detection and car crash detection have been credited with saving lives.
The company frequently shares customer testimonials in its marketing, highlighting stories of people who, after receiving heart-related alerts on their Apple Watch, sought medical attention—potentially saving their lives. However, excessive alerts could also cause unnecessary anxiety.
The FDA had previously approved two Apple Watch features as a direct-to-consumer wearable ECG device, starting with the Series 4 in 2018, which notifies users of irregular heart rhythms.
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