It is now a well-known fact that the fourth generation of the Apple Watch is significantly more capable than any of the generations that arrived before it. Bigger display, newer hardware and advanced methods for monitoring an electrocardiogram (ECG) as well as the ability to detect and notify the user of an irregular heart rhythm (also known as Atrial fibrillation, or AFib). These new features also come with the US Food and Drug Administration (FDA) stamp of approval. Apple says the Watch Series 4 has been granted a De Novo classification by the FDA.
“This opportunity is supported by a new technological paradigm of digital health tools, like apps, that enable consumers to have more active engagement and access to real-time information about their health and activities. These tools allow consumers and providers to supersede the traditional, physical constraints of health care delivery and make the most of the opportunities offered by mobile technology,” said FDA Commissioner Scott Gottlieb, and Center for Devices and Radiological Health Director Jeff Shuren, in an official statement.
But what does all this mean?
Simply enough, this means that the Apple Watch has been cleared by the FDA as a device for ECG and AFib screening. The Apple Watch Series 4 has been classified as a Class II device by the FDA. “FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type,” says the official order. Interesting to note that the FDA has not classified this as a Class III device, which are not only more complex and complicated devices, but aren’t available for over-the-counter purchase and need compulsory approvals as well.
The FDA also determines that the ECG app is not recommended for users with with other known arrhythmias, and the AFib screening apps aren’t recommended for users who may have been previously diagnosed with AFib. The FDA also suggests that both apps shouldn’t be used by users below 22 years of age.
The ECG app is essentially a software-only mobile medical application on the Apple Watch Series 4, which will create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. Similarly, the AFib feature also analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user as required.
As with most fitness-based devices and features, it is important to note that these are only the first level of detection. Depending on the data that the Apple Watch or indeed any other fitness wearable may offer, it is important to get clinical tests done and follow that up with a doctor, rather than starting any medication simply based on the software results. There far too much of a change even now, with sophisticated hardware and software at play, for irregular detections, incorrect detections and even false positives.
Also read: The Apple Watch is All Grown up, And is Smarter Than Ever Before
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