Back in 2018 Apple introduced ECG heart monitoring features on the Apple Watch. It wasn’t available in Australia but has now finally rolled out.
These heart-related features allow the devices to monitor low heart rate detection and irregularities. The aim is to provide users with more of an understanding of what’s going on with their heart so they can get proper medical attention if needed.
It shouldn’t be considered as a full-proof medical device as it’s not medical grade.
When the ECG functionality was first introduced we discovered that it wasn’t coming to Australia. We also spend the next few years following up with Apple and the Therapeutic Goods Administration (TGA) to find out how far off it was.
Back in September 2020 the TGA told Gizmodo Australia it “[had] not received any applications for products manufactured and/or supplied by Apple, nor is there any Apple device included on the ARTG.”
But that has since changed.
We first discovered that the electrocardiography, or ECG, functionality was approved for Australia back in March.
A filing with the TGA revealed the approval and the attended purpose of the features. But at the time we didn’t know when it would actually roll out in Australia.
Here’s the entire filing:
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.
Apple ECG has now arrived in Australia
The latest Apple WatchOS 7.4 update has brought a few changes with it, one of which is the long-awaited ECG functionality for Australia, including irregular rhythm notifications.
It’s available now and is compatible with Apple Watch Series 4, 5 and 6.
Disclosure: the author owns shares in Apple.