Australian shoppers hoping to get their hands on Apple Watch’s next-generation heart monitoring feature will miss out – with the local regulator confirming it is not approved for sale here.
Apple (Australia) told The New Daily that its electrocardiogram (ECG) app, which is capable of tracking and recording electrical signals from your heart in 30 seconds, will not be available in the Australian model for the time being.
“The ECG feature is US only at this point,” its media spokesperson said. The company did not respond to further questions regarding the possibility of making the software available to Australians in the future.
But, unless the tech giant seeks approval from the Therapeutic Goods Administration, it will be illegal to sell the product in Australia.
“Such a product would need to be regulated in Australia as a medical device and suppliers must apply to the TGA … before they can legally supply the product in Australia,” its spokeswoman confirmed to The New Daily.
Apple has not made any applications to the TGA seeking approval to market its new ECG function, nor is there any Apple device included on the Australian Register of Therapeutic Goods (ARTG), the spokeswoman said.
Any goods imported for personal use by an individual–or their immediate family member–do not need to be registered on the ARTG. However, the ECG app required to use the new function will also be limited to the US app store.
The potentially life-saving app, revealed at Apple’s product launch in California on Thursday, can also detect signs of atrial fibrillation – a form of irregular heart rhythm that causes a third of all strokes in Australia.
A second app analyses pulse rate data to identify and alert users to the irregular heart rhythms.
Unlike other similar products, the mini-ECG feature of the Apple Watch Series 4 has been FDA-approved as a medical device for direct use, meaning users won’t need to make a doctor’s appointment to capture and analyse any irregular heart activity.
It has even been given a hearty tick of approval by the American Heart Association.
A similar product that detects atrial fibrillation, by AliveCor and capable of syncing with older Apple phones and watches, is listed as a medical device in Australia.
Heart health experts remain cautious
“If you find atrial fibrillation in a younger person, which is under the age of 65 in this context, very often it doesn’t require treatment because they don’t have the other risk factors for stroke or death,” Ben Freedman, a cardiologist and professor at University of Sydney’s Heart Research Institute, said.
Professor Freedman said a more promising feature of the new Apple Watch is its fall detection sensor – it sends an alert to the user if they suffer a hard fall and automatically calls emergency services, if the alert is not cancelled.
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Since risk factors increase with age, routine screening for atrial fibrillation in Australia is currently only recommended for people over the age of 65.
The risk of ‘false positives’, where a device indicates someone might have a condition or health issue when in fact they do not, may lead to anxiety and stress in some people, the foundation said.
“For those people who already have atrial fibrillation, the use of such technology may also carry a risk of a ‘false negative’. That is, prompting them to unnecessarily change or stop their AF or stroke prevention therapy,” she said.
“GPs are the best source of information for preventative health care – they are best placed to assess a person’s health as a whole, co-ordinate and follow up any investigation, and provide consistency and constancy of care.”
Official FDA documents state that Apple’s ECG is not intended for people under 22 years old, and should not replace traditional methods of diagnosis or treatment.
A spokesperson for Australia’s medical technology industry body, the MTAA, said it is working with the TGA, CSIRO and other stakeholders to make sure “our regulatory environment is fit for purpose including new technologies like software as a medical device”.