Apple Watch‘s ECG feature to launch in Australia after the government approved the feature.
The news was first discovered by 8-Bit, they found that Australia’s Therapeutic Goods Administration (TGA) approved Apple Watch’s ECG feature under ”Medical Device Class IIa”.
This is what the TGA stated in the document of approval:
“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 electrocardiogram (ECG) similar to a Lead I ECG. The 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 arrhythmias.Â
The app is intended for over-the-counter (OTC) use. The 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 has been expanding its ECG feature to many Apple Watch users around the world, with many more on the way for government approvals.
The ECG feature is available in 63 countries, the function lets you measure the oxygen in your blood, which has saved many lives. ECG is supported on Apple Watch Series 4, 5, and 6, but not on SE.
