Apple Watch’s Heart Monitoring Features Finally Approved For Australia

Apple Watch’s Heart Monitoring Features Finally Approved For Australia
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Over two years ago ECG features were introduced to the Apple Watch, but not in Australia. That has finally changed.

Electrocardiography, or ECG, functions were first introduced to the Apple Watch in September 2018. This allowed the devices to monitor low heart rate detection and irregularities.

While it’s certainly not meant to be used as a full-blown medical device, it’s supposed to give people a better idea of what’s going on with their heart and whether they should consider seeking proper medical attention.

But despite the hype around these new features at the time, we found out quite quickly that the functionality would not be coming to Australia.

In the years since we have been tracking the progress, which for the most part has been non-existent. In fact, the TGA told Gizmodo Australia in September 2020 that it “[had] not received any applications for products manufactured and/or supplied by Apple, nor is there any Apple device included on the ARTG.”

Clearly, that has now changed.

Apple Watch ECG is on its way

In early February Australian Apple Watches got a step closer to heart monitoring, with its Irregular Rhythm notification being approved by the Australia’s Therapeutic Goods Administration (TGA).

Now a TGA filing has revealed that ECG functions have now also been approved by the organisation in Australia. The filing indicates that the start date for this was March 2, 2021.

Here is what the filing says about intended purpose of the ECG features on the Apple Watch:

The ECG app is a software-only mobile medical application that is intended to be used with the Apple Watch to create, record, store, transfer and display a single-channel electrocardiagram (ECG) similar to a Lead I ECG.

The ECG app determines the presence of atrial fibrillation (AF) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrythmias. The ECG app is intended for over-the-counter (OTC) use.

The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation with a qualified health professional.

The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AF from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The

ECG app is not intended for use in people under 22 years old.

Despite the approval, the ECG features are yet to roll out on Aussie Apple Watches. Gizmodo Australia has reached out to Apple locally about when an update might drop.

Disclosure: the author owns shares in Apple.