TGA approves Apple Watch Irregular Rhythm Notifications, ECG approval imminent

The Apple Watch’s credentials as a health device has received a boost after the Irregular Rhythm Notification feature was approved by the Australian Therapeutic Goods Administration (TGA).

But Apple is still awaiting approval for the ECG (electrocardiogram) feature which was submitted to the TGA some time ago.

The Irregular Rhythm Notification, once installed through an Apple Watch update, will be able to pick up an irregular heart beat rhythm and provide an alert.

This irregular rhythm could be a sign of atrial fibrillation – a condition that would require the patient to have an ECG to get a more complete examination of their heart rhythm.

Once the ECG is approved by the Australian TGA, users will be able to place their finger on the Apple Watch crown and see a live readout of their heart beat.

The approval of the Irregular Rhythm Notification by the TGA suggests the approval for the ECG functionality for the Apple Watch in Australia is not far away.

ECG has been a feature of Apple Watch in other countries, including the US, for some time.

The Withings ScanWatch was the first smartwatch in Australia to have ECG approved by the TGA in November 2020.

Heart arrhythmias are often underdiagnosed and easily missed if symptoms are not occurring during a doctor’s visit.

With the Irregular Rhythm Notification and ECG, users can detect if their heart rhythm is slow, high or showing signs of atrial fibrillation through a proactive heart scanning feature.

The Irregular Rhythm Notification will become active after Apple issues a software update for the Apple Watch.

The recent watchOS 7.3 software update included the ECG app for Japan, the Philippines and Thailand and Irregular Rhythm Notifications in those same countries.

That is yet another indication the Apple Watch ECG approval for Australian users is imminent.

But for now Apple Watch has received TGA confirmation for Irregular Rhythm Notification in Australia.

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