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
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.
Where are people getting this "one node" misinformation? The apple watch is no different to a Kardia device.
The Kardia has two electrodes that measure the voltage between one hand and the other by using the fingers or thumb of each hand. It also works by measuring the finger of one hand and the wrist of the other - I know because I have tried it.
The Apple watch also has two electrodes that measure the voltage between one hand (fingertip of right hand) and the other (wrist of the left hand) or vice versa. The wrist electrode is on the back of the watch.
Actually the COO never said "applications" because that isn't how the system works. He said they are working with agencies all over the world and by and large they have been highly successful. So if they have 40 or so agencies that have granted approval and in this case one that hasn't is that an Apple issue or the agency they are dealing with?
And Apple is better at secrecy than most spy agencies around the world.
Firstly I only use apple features for indicative values not medical value.
if you few apple has misled you consumer law would support you obtaining a full refund on the device.
the watch is good for many things so why detract from the purchase with negativity.
Apple Pay is probably the best example of what you are saying.
I bank with a bank that provided Apple Pay support recently that is not apples fault.
call the TGA or ACCC seek professional advice get fact not speculation on the matter.
I am more concerned you place so much value in a PED that is primarily an wrist interface to apple iPhone
I agree with you on that point but the Australian government is on a witch hunt on all foreign companies at the moment. They both don't care in the end of the day and we need drastic change on these issues for all who will benefit a resolution.
It's time for both government and big corporations (Apple especially) to work together to find a solution to their problems and resolve this issue once and for all.
Deggie,
Why ask me to explain why Apple have not applied?
I do not have insider information from Apple.
There have been plenty of opinions posted on why they have not.
But no facts.
Lets takes this position “Apple have not applied” - there is no evidence to show that they have.
Perhaps this will change after February.
Whatever...
Why is it irrelevant? So what is you experience with how these approval systems work?
Neither Apple nor the TGA are allowed to comment on ongoing discussions. The TGA has already said this. But Apple never does this anyway.
How would that not solve your issue? If the TGA rejected Apple's application then Apple would be free to say that the feature will never be activated on watches sold in the Australian market. They will have told you what is going on.
Actually, just today I read that Apple has revised its ECG algorithm to version 2. It’s their biggest update since the first released it.
Here’s hoping to the possibility that this algorithm revision would line it up for possible compliance with TGA requirements. Hence if we are lucky Australia may be next....one could dream yeah. Cross your fingers.
It’s really frustrating especially as apple are not transparent and specifically list that these features are NOT available in Australia. Me, like so many other people, have upgraded from other smart watch’s to an Apple Watch only to be let down.
I really hope they apply to the TGA soon.
If the Aus Government won’t approve the new 2020 Apple Watch as a medical ecg device. Just to please them say in Australia it’s a medical toy not to be taken seriously we believe it’s close to accurate but consult your usual medical protocols and avenues .... still provide the ECG on the watch. It’s stopping me from buying it ... if I buy a product I don’t want less then others. I want the same. A full product.
Been here a long time? There are moderators here to be sure to watch decorum and there are Community Specialists that answer questions that do not have a response for 12 - 24 hours. Once in a blue moon an engineer might contact someone in a technical problem thread. But there are no Apple executives here.
Send feedback to Apple if you want them to know your feelings.
I agree. What’s their problem? Perhaps they are trying to market it as something it’s not. ie. making it sounds like it’s better than it is and the TGA won’t approve it. That if at all the have submitted at all. The whole thing is so disrespectful to the Australians that bought these watches as per marketed at the time of sale with ECG.
Any user who is a Level 4(?) and higher can report your posts for moderation. Threatening law suits against Apple is one that will almost surely get a comment removed.
These forums are on Apple's dime, so yes, Apple IS God here. If you break the rules, you get moderated. If you continually break the rules, you get a time out. If you continue to break the rules after a time out, you get a permanent vacation.
Hasta la vista baby.
I'm sure that with the eminent arrival of the next versions of the expected updates to the OS for all Apple devices that Australia will get ECG activated. But there are a number of issues in these updates Apple has to get right, such as the introduction of enhanced privacy with anti-tracking through apps. So these updates have been going through extended beta testing. More so than usual.
Can you confirm, if Apple has submitted request to TGA for approval ? May be we can followup about that request. Thanks.
He already answered your question. Page 2, response 10
You need to read this entire thread and some of the links posted. Not just the Gizmodo article.
Apple Watch: ECG In Australia
