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Apple Watch ECG monitoring one step closer to approval in Australia

It's been a long time coming but the Apple Watch's irregular heart rhythm notifications have finally been approved for use Down Un...

It's been a long time coming but the Apple Watch's irregular heart rhythm notifications have finally been approved for use Down Under by Australia's Therapeutic Goods Administration (TGA), as first reported by EFTM.

This feature allows a user's heart rate to be monitored in the background and a push notification sent automatically when the Apple Watch detects an irregular heart beat. It's an important health-monitoring feature that could help an estimated 475,000 Australians suffering from atrial fibrillation (Afib) in preventing a heart attack or stroke.

Every Apple Watch model is capable of keeping tabs on your heart rate and sending these newly-approved irregular rhythm notifications, so even Aussie owners of the earliest models can make use of this feature.

With that said, the popular ECG (electrocardiogram) sensor and corresponding app are only available from the Apple Watch 4 and newer models, and are yet to be approved for use in Australia. The ECG app is still awaiting the green light from the TGA (an organisation run by the government's Department of Health), but this latest approval gets us one step closer to in-depth heart monitoring for Apple Watch users.

Hearty approval

There's no clear indication as to why this approval process has taken so long. Speaking to Gizmodo in 2020, the TGA said Apple hadn't submitted any devices or the accompanying paperwork for approval.

There's also no precise timeline from either Apple or the TGA on when the ECG app will be available for use Down Under. The TGA is currently overhauling its medical device software regulations for wearable manufacturers that will "commence on 25 February 2021 for new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG)" .

So, at the very least, we'll need to wait till the end of the month for the Apple Watch's ECG app to become available for use in Australia.

In the meantime, though, Withings beat every other major brand to the punch, getting clinical approval for its ScanWatch in November 2020 – the only TGA-approved ECG-enabled wearable available in Australia.



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