Finally, It’s here – the much anticipated and many would agree long overdue Apple Watch ECG feature has been approved by the Therapeutic Goods Administration (TGA) for use in Australia.
We had hoped the TGA was on it’s way toward approval with the earlier approval of the Irregular Rhythm Notifications by the TGA, however nothing is certain until it’s rubber stamped.
TGA’s approval states that “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.
Importantly, while it is a medical device given the TGA approval, the TGA approval points out that the Apple Watch ECG feature in Australia 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. “
As such it is “not intended to replace traditional methods of diagnosis or treatment.“
The only final qualification the TGA approval for Apple Watch ECG in Australia states is that “The ECG app is not intended for use in people under 22 years old.“
With this approval, we can assume Apple will enable the feature in the next WatchOS update – when that will happen is not clear, but we should expect it within a few months.
ECG is an app that will be enabled on Apple Watch Series 4, Series 5, Series 6 once the update is rolled out.