Apple Watch Series 4 ECG ‘FDA Approval’ Comes With These Warnings And Limitations For The App Use

The September 12 event by Apple undoubtedly had the Watch Series 4 as its highlight, among the three more iPhone models unveiled. A major talking point has for those excited for the Watch has been the electrocardiogram (EKG) embedded into the device to assess the user’s heart rate in real-time. Accompanying this is a notification system in place that alerts the user in case his or her heart rhythm is irregular. Both the features will be rolled out later in 2018 as per the company. The question, however, lies with the ‘FDA approval’ that both the applications have got. What exactly are these cleared for and what are the limitations to the use of these apps, we find out here.

An important thing to note is that both the EKG and irregular rhythm notification on the Watch Series 4 are not meant to be used by people under the age of 22. The same FDA Clearance also mentions that the ECG app “is not recommended for users with other known arrhythmias (irregular heartbeat)”. Meaning only users who are already free from any medical condition leading to an irregular heartbeat can find a use for the ECG app in the Apple Watch Series 4.

Apple Watch Series 4 ECG 'FDA Approval' Comes With These Warnings And Limitations For The App Use
Apple Watch Series 4 ECG ‘FDA Approval’ Comes With These Warnings And Limitations For The App Use

Another notable indication on the clearances is that both the apps should not be mistaken for a doctor’s alternative. Naturally, the apps are only meant to measure and keep a record of the user’s health data, and even alert the user in case of discrepancy. The apps cannot replace traditional ‘treatment and diagnosis methods’.

There also seems to be a perplex regarding the “FDA approvals” that many seem to mention for the Apple Watch Series 4. In case you happened to watch the Apple ‘Gather Round’ event, the term used to indicate the apps’ FDA approval’ was in fact “FDA Clearance”. The distinction here lies in the “risk and benefit” involved in both categories. While the FDA Approval is given to the Class III products involving high risk but delivering higher benefit to the end-user, the Class I and Class II categories involve “lower risk products”. The Watch Series 4 lies in the class II category and hence, just the FDA Clearance. As per FDA, class II (special) controls offer “reasonable assurance of the safety and effectiveness of the device type”. A device type, that is the first-of-its-kind. This is specified by the ‘De Novo’ classification that the association has granted it.

In its entirety, the ECG app “is a software-only mobile medical application” whose sole purpose is to present a person’s heart rhythm in a user-friendly and understandable data format which can also be stored and used for medical assessments. The diagnosis, and the treatment of any medical condition detected, should be best left to the professional help of a cardiologist. Abiding by this law, the concerning features on the Apple Watch Series 4 should come in handy for the end-users to keep a check on their health. A recent example of this was seen back in May when the Apple Watch was hailed to save a 76 year-old man’s life with its heart rate alert.

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