Apple Watch’s ECG app has finally been approved in Australia after receiving approval for Irregular Heart Rhythm notifications last month.
The Australian Government’s Therapeutic Goods Administration (TGA) approved the ECG feature in the country yesterday under “Medical Device Class IIa,” according to a document first spotted by The 8-Bit. This means that Apple Watch users in Australia will soon be able to access the ECG app.
According to 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 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 arrhythmias.
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.”
It’s unclear when Apple will make the ECG app available for users in the country, but approval is an indication that a launch is imminent.
The ECG app on the Apple Watch, which is intended for people over 22 years old, is used to conduct an electrocardiogram test which records the timing and strength of the electric signals that form the heart beat. Apple says that by using ECG, doctors can gain insights about a patient’s heart rhythm and look for irregularities.
The ECG app is only available on certain Apple Watch models including Series 4, 5, and Series 6, and accessible in a limited number of countries and regions. Here’s a list of all the countries the ECG app is currently available in.
Apple introduced an improved version of ECG called ECG Version 2 which introduces increased heart rate test limits and enhances accuracy.
Apart from Australia, Apple’s ECG app for the Apple Watch was also spotted in a regulatory filing in Malaysia, meaning the service could launch there anytime soon as well.
In order to set up the ECG app on your Apple Watch, you’ll need to first set it up within the Health app on your iPhone.
