Apple Watch Receives FDA Approval For AFib Tracking Feature

The U.S. Food and Drug Administration has given 501k clearance to Apple for a new smart watch feature. The clearance comes as wearables continue to be integrated into healthcare provision. Today, wearables can help measure data related to temperature, blood pressure, blood oxygen, breathing rate, physical movement, and the electrical activity of several organs. Apple has utilized this technology to design a feature which is capable of detecting signs of atrial fibrillation (AFib) in its user. 

The Food and Drug Administration approved the Apple Watch as a viable tool for detecting irregular heart rhythms in 2018. Although the Watch’s electrocardiogram alerts users to signs of irregular heart rhythms, the feature does not offer assistance to users for managing their condition after receiving a formal diagnosis. Apple has addressed this shortcoming with their latest feature. AFib History will allow users to record and examine lifestyle factors such as sleep, exercise, and weight that may affect their heart rhythm and enables users to track the frequency of their condition. The feature helps users identify the time of day or week that the user’s AFib is most frequent. The data is recorded on the Apple Watch and can be viewed using the Apple Health application. The data can then be used by a clinician to provide more suitable treatment to the patient. 

In a statement provided at a company event, Apple’s VP of Health Sumbul Ahmad Desai said “We hear from so many of you who have received an atrial fibrillation alert and sought potentially life saving care, So, we also wanted to offer support once you’ve been diagnosed. When living with this condition, it’s important to understand the time you spend in AFib because it may relate to your risk of serious complications such as stroke”.

Google later received 501k clearance from the FDA for the cardiac monitoring feature on the Zio Watch. The Watch’s new feature will be used to compete with the Apple Watch in the market of wearables. Experts believe the Zio watch has the ability to stand out due to its artificial intelligence capabilities. However, the results will not be available until 2023.