EXCLUSIVE: Apple Watch gets closer to TGA Approval for ECG with Approval for Irregular Rhythm Notification

When the Apple Watch Series 4 was announced over two years ago one of its biggest selling points was the ECG app, allowing users to get detailed analysis of their heart rate and alerts for any irregular rhythm. Since then, we’ve had no sign that Apple was any closer to getting approval by the TGA here in Australia – Until now.

EFTM can report that the Australian Government’s Department of Health run Therapeutic Goods Administration has approved the Irregular Rhythm Notification Feature of the Apple Watch and added it to the ARTG – the Australian Register of Therapeutic Goods which allows that to be used in Australia.

This does not mean the Apple Watch ECG function is medically certified for Australia, but it does mean Apple is submitting it’s devices and software for testing and approval, something we’ve had no clarity on to this point.

When questioned on this in the past, Apple COO Jeff Williams said of ECG and Irregular Rhythm Notifications “we’re working hard to bring them to customers around the world.”

It can be assumed this is still Apple’s position, but we’re unlikely to hear anything from Apple until the full ECG function gets approval.

Irregular heart rhythm notifications are just the first step. Also introduced with the Apple Watch Series 5, the idea is for the regular “background” heart rate testing would allow the Apple Watch to detect any Irregular heart rhythm – from there a user could then launch the ECG app and perform a more comprehensive test.

If you are notified of an Irregular heart rhythm, but don’t have the ECG function, the ECG taken when you do finally see a doctor may well not pickup the same issue. Having the ECG function linked to the same device as the Irregular heart rhythm means an almost immediate ECG can be performed, the output of which might serve to help a medical professional to diagnose any issues.

As stated in the approval, “The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user. The feature is intended for over-the-counter (OTC) use. “

Importantly for those who might see this as the be-all and end-all of heart monitoring, the approval also states that “It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis.”

Regarding Apple Watch ECG Australia – the TGA goes on to point out that “The feature is not intended to replace traditional methods of diagnosis or treatment.”

While the functionality is strong, it’s also “untested on those under 22 years of age, and is not intended for those who have previously been diagnosed with AFib.”

Despite being the first consumer wearable to feature ECG, Apple was not the first to gain approval in Australia. That went to the Withings ScanWatch late last year – just why it is taking so long for Apple to either apply, or get approval – we’ll likely never know.

No word on the full ECG approval. When questioned on the process, the TGA previously told EFTM “The existence or non-existence of an application for inclusion of therapeutic goods in the ARTG is generally considered to be commercially confidential information.  In the absence of publicly available information indicating that an application has been made to the TGA for inclusion of therapeutic goods in the ARTG, the TGA is generally subject to a legal duty of confidence in respect of such information.”

We shall continue to wait, but expect news on the ECG functionality sooner rather than later if this first approval is anything to go by.