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.
Point 1 in the referenced TGA document in that thread states:
"We support the TGA in developing and implementing regulations for software
(including Software as a Medical Device) that are standardised and consistent
with international controls."
Based on that recommendation, the international bodies in those countries who have already approved ECG support in the Apple Watch provides a sufficient baseline of professional consensus who appear to be happy with the ECG value proposition for consumer health.
TGA, if you want a hand out...just ask for it. Sheesh. Australian consumers will hold you accountable for us not being able to use innovative technologies to support telemedicine. Especially in the COVID ERA!
Doesn’t matter what the method is anyway. If they are providing ECG, first question is:
Eitherway, I’m a sucker for buying Apple Watch 6 knowing Apple won’t focus on ECG.
Mystic Cheese wrote:
• Doesn’t matter what the method is anyway. If they are providing ECG, first question is:
Is it approved by TGA for Australia?
• Hence, is it available for sale in Australia?
• Why would withings have the resources to clinically prove their ECG works and Apple with their Trillion dollars cannot?
Eitherway, I’m a sucker for buying Apple Watch 6 knowing Apple won’t focus on ECG.
It is not about testing. It is about the TGA rules for ECG. The Apple Watch uses a method excluded by the the TGA rules. All the testing in the world, will not get past the current TGA rules. Withings most likely used a different method that is allowed by the TGA rules.
Of competency or inclination? Everybody pays a premium for the features in Apple Watch, even if they are not available in a particular market. Two years ago I was promised ECG was coming to Australia when I purchased Apple Watch 4 (upgrading from the original Apple Watch) and I’m still waiting. To add insult to injury, a competitor was approved by the TGA (Australia’s FDA)! This makes me feel like Australia isn’t a priority for Apple and they will only cater for markets that have more customers. This is fine if we paid less for products as compensation for the features we are unable to use. Thing is, we pay more than other markets! I understand reasoning including geographic location and market size, but Australia is an Apple devotee market with more than 50% market share (iPhones) and a similar figure for smart watch penetration. They should treat us as valued customers and not embarrass themselves by allowing a competitor to be approved for a relatively archaic feature when viewed from world markets. I live and love Apple products and spend a great deal of money to surround
myself of them, this has left me veritably disappointed.
They all use proprietary technology, not just Apple. I never said anything about TGAs red tape. I have said that I have no doubt that staff at that TGA and Apple have had discussions. I don’t doubt that Apple’s technology does not currently meet the regulations currently in effect from the TGA. These regulations will purportedly be updated in February 2021.
in the meantime there is nothing to be gained by Apple applying. Perhaps what Apple should do is withdraw all Apple Watch models except the Series 3 from the Australian market and move on. Note that the Withings watch with ECG is not approved in the US.
That is based on experience with health agencies and the fact that in public statements from the TGA about this the have said they do not disclose the nature of discussions they have had with people they are working with.
Again, why would Apple just decide to ignore Australia?
And I've asked you more than once, why would Apple do this?
I've also read reports in Australian media (isn't the World Wide Web wonderful) and they don't say that Apple has done nothing. They report that the TGA has said Apple has not made an application. But then they go on to say that discussions the TGA has with 3rd partied are not disclosed. Why would they say this if they hadn't had discussions with Apple.
And almost all western government health agencies play this "they haven't applied" game. A company cannot apply until they submit certain data to the approving agency and answer all questions to the agencies satisfaction. If they have not done so the approving agency will not accept the application. A company will also not apply if the agencies written rules will not allow the technology used.
If you are happy with your Watch good for you, keep using it and wait until February (it was articles from Australian media which has reported that new regulations would be released in February, a delay from October).
But if you can explain why Apple would just sit back and do nothing to get approval in Australia I would be happy to read it.
It would not solve my issue.
Please again read what I have posted - my issue is that Apple will not tell us what is going on with Australian approval.
Your experience of taking 13 years to get health authority approval on something is irrelevant,
littlepiko wrote:
I am woohoo very disappointed. I have a heart murmur and bought the series 6 to help monitor my heart. Now I find ecg is not available hear. This is false advertising apple. Please request approval so we can get it. Also have problem with sleeping app. My old fitbit monitored sleep cycles. I can't seem to get this up on apple 6. Can someone tell me if it's available and how? Otherwise like most components except battery.., shocking.
In what Australian Print, Radio, TV or Country Specific Web Page did Apple advertise ECG in the Apple Watch sold in Australia?
It is disapointing that your government has rules that will not let Apple enable ECG in your country. And yes, we know Apple did not apply, because why apply to be rejected, because they have Australian lawyers that can read the Australian rules and know what the out come will be.
We have no way of knowing if there is an ongoing application. The publicly accessible list is only approved goods. Anyone saying Apple hasn't done their part is making assumptions. We won't know until it is approved by TGA
Who has to take the first step in getting ECG approved in Australia. Does Apple have to apply then wait for the govt ?
Australia is a nanny state because it actually has regulations on what it defines as medical devices? Bit different to the for profit medical system you have in the States.
Government tend to frown on companies that use semantics to get around a regulation.
Apple hasn't made an application to Therapeutics Goods Association in Australia........
The heart monitor on the Watch functions in Australia, there just isn't any software on the watch in AU to operate the ECG function. Silly, useless suggestion.
Apple Watch: ECG In Australia
