Apple Watch: ECG In Australia

Ok, it’s now 04 July 2020.

So, when will ECG be released in Australia.

I upgraded my Apple Watch specifically to get ECG, promised by Apple at that time.

Who is responsible in the Medical profession here for this absurd level of procrastination, please tell me...

Apple Watch

Posted on Jul 3, 2020 5:16 PM

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Posted on Feb 3, 2021 11:43 AM

Given the registration hasn't occurred the issue is hardly solved!

Interesting that Apple doesn't seem to be able to negotiate the relatively easy TGA registration process, especially since there exists what is known as a Global Medical Device Nomenclature code (recognised by the TGA) that covers the hardware and another that covers the software! Would hate to think it is just laziness on Apple's part or that they won't provide any details to TGA, which to be frank is usually less than the US and the same as the UK and EU.


For information, the relevant codes are below. Registration takes less than a day to complete the form and usually an answer is received within a couple of days.

Hardware

Name

Wearable multiple physiological parameter recorder

Definition

An electrically-powered, wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiograph, haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a local application (e.g., smartphone) or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns).


Software


Name

Smartphone camera home cardiovascular monitoring application software


Definition


A software program designed for use in a smartphone/watch with a built-in camera to periodically measure, via transcutaneous optical reading, and display cardiovascular parameters (e.g., pulse wave, heart rate variability, SpO2, blood pressure, LVEDP) for assessment of cardiovascular function to assist diagnosis of disease (e.g., arrythmia, cardiac autonomic neuropathy); it may also be used to provide general lifestyle/fitness advice or during a controlled Valsalva manoeuvre to facilitate cardioversion of supraventricular tachycardia (SVT). This is a home-use device which may allow for remote communication of data with a clinician; it may in addition be used in a clinical setting.

425 replies

Sep 19, 2020 7:01 PM in response to miloks

The solved was awarded by the original poster the only one that can mark it that way. He was satisfied with the answer. Complain to him not us. How is it politically charged to ask your citizens to do something that would benefit them? Is that not allowed under your political system? No one that doesn’t live in Australia cares about your countries rules. They are your problem not ours. If you can’t or won’t petition to change them to keep up with new technologies don’t complain to us. We are volunteers who give our time and knowledge to point out possible reasons for why it might not be approved there. If you don’t like our help or opinions then don’t ask for them.


if you read the entire thread you would see some good answers as to why Apple may have not submitted an application for approval. Why bother spending time and money submitting a device for approval when you know that it will be turned down. Apple didn’t get successful wasting money that way.

About your statement that if we’re not in Australia we shouldn’t comment about anything to do with y’all. You do realize this forum is in the USA with people from all over the world asking questions and submitting answers. If you don’t want advice from foreigners don’t ask here. That will be the majority of the people.




Sep 20, 2020 7:28 PM in response to SamoAt18

Exactly. And to make matters worse I specifically asked staff about the ECG and irregular rhythm features based on hereditary health concerns.


In response to another user’s comment about it being a purchasing mistake - yes it was, but it was helped by advice given by specialists who should quite frankly know better. Indeed, asking staff is considered PRODUCT RESEARCH. I’ve gone straight to the source and the source was wrong.


As for the value of the watch sans these features, you can’t calculate that based on what other features you use. You would have to base value on an average worth of all features and manufacturing costs, design, firmware, marketing, etc, etc. only Apple can do this as they alone have set the price for the product based on all of those factors.


You would also look towards other technology to consider features and price. Look to computers for instance - if you want to add functionality and enhanced features, you have to pay for it by purchasing software or hardware components (like RAM).

Sep 20, 2020 7:55 PM in response to gpacgc

Patentlyapple is not an Apple endorsed website. They can post whatever gibberish they want. Nonetheless the back of the Watch does not count as an axis. The crown is the only axis on the watch for ECG (per your country's definition of a ECG axis.) Your dang website that you referenced looks like a blog.


I will also say that further discussion in this thread doesn't speed up Apple into making ECG available in Aus.

Sep 20, 2020 7:51 PM in response to deggie

The price is based on ALL features. If you don’t get all of those features, why should you pay for everything? There’s no set price for other large purchases - you don’t pay for what you don’t get when it comes to other items like cars, televisions, computers, etc. Why should I pay for features I don’t get with the Apple Watch?


Yes, the staff said those features were available in Australia. When I realised those features weren’t available, I called both of the stores I visited and asked to speak with the manager. I have submitted my feedback to the stores I received this advice from. I also asked if I could get my older watch back and return the Watch I purchased, and I was told no - my trade-in had been sent away already. There were no older referb models available to exchange for either, so it further limited my options, but either way I’d be either out of pocket, or without a watch completely.

Sep 20, 2020 7:55 PM in response to gpacgc

both use the same measurement technique.

And yet as I quoted Apple before in this thread, Apple says that it doesn't. Apple described how the watch measures ECG using a combination of the Digital Crown lead and the UV LEDs that measure blood flow in the vessels beneath the watch. The Kardia does nothing like that.


You need to button it up and move on. You're rearguing stuff already covered here.

Sep 20, 2020 8:11 PM in response to deggie

Thank you for the information that Australia will supposedly be modifying regulations in January 2021 - would you mind sending me your source please? I would like to pass it on to the Gizmodo journalist along with the post that ‘supposes’ Apple have not applied for ECG approval because they know their technology does not meet the Australian standards.

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Apple Watch: ECG In Australia

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