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ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom
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You aren't prevented from getting the 10-lead EKG after the watch sends you to the doctor. However, are you getting that 10-lead EKG otherwise?
Hi, I'm over here. When you are finished arguing with that straw man, we can continue our discussion.
To be clear, I never said that they should be exempt from regulation. I did not once say that Apple should include it prior to being authorized. You, on the other hand, seem to be arguing against its inclusion at all because you think it is wildly inaccurate. The FDA will make their approval decision based on the tests that Apple has performed. Apple must feel confident that they will get that approval or they would not have been likely to mention it on stage.
I trust the FDA's analysis hands down over your armchair analysis.
Anything to do with health in the U.K. doesn't just take years it can take Decades. The healthcare may be free but it sure isn't fast.
Yes, we need to be saved from ourselves. How dare the people take responsibility for their own healthcare.
I’m sure this is something Apple thought about however the selling point here is the feature that’s approved by a regulated body
It’s going to be an interesting clash of cultures seeing Silicon Valley’s ‘fail fast & fix later’ culture meet the world of medical devices...
...A world where your product claims absolutely must work as you say they do & you’ll need to be able to provide extensive evidence to regulators in order to launch it.
Perhaps this is Apple practicing changing its software practices for the Car - another product category where it’s pretty important not to have any major bugs.
P.S. let’s all try and discuss this without it falling into a debate about insured vs free healthcare...
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I wonder if this will lead to people (outside of the US) buying the series 4 next year (when this might be approved) over the series 5, when that’s presumably going to have new health monitoring functionality (which might not be available outside of the US)
...A world where your product claims absolutely must work as you say they do & you’ll need to be able to provide extensive evidence to regulators in order to launch it.
Perhaps this is Apple practicing changing its software practices for the Car - another product category where it’s pretty important not to have any major bugs.
P.S. let’s all try and discuss this without it falling into a debate about insured vs free healthcare...
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We are happy to pay more for less features
I wonder if this will lead to people (outside of the US) buying the series 4 next year (when this might be approved) over the series 5, when that’s presumably going to have new health monitoring functionality (which might not be available outside of the US)
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So why not disband medical boards altogether and let people take responsibility on who they want to pay to provide them with medicine, surgery etc.?
Is your laissez-faire attitude a philosophical one or does it only pertain to Apple products?
I don't why approval should take long at all. I can already buy a blood pressure monitor with fibrillation alert:
https://www.boots.com/boots-pharmaceuticals-advanced-blood-pressure-monitor-10209953
And an ECG monitor:
https://www.amazon.co.uk/Prince-Col...ns&keywords=atrial+fibrillation+monitor&psc=1
https://www.boots.com/boots-pharmaceuticals-advanced-blood-pressure-monitor-10209953
And an ECG monitor:
https://www.amazon.co.uk/Prince-Col...ns&keywords=atrial+fibrillation+monitor&psc=1
As an Amazon Associate, MacRumors earns a commission from qualifying purchases made through links in this post.
Before launching this feature they should have sought approval in major markets such as EU, Canada and Australia. Many buy the watch with the ECG capability in mind but won’t be able to use it any time soon if at all outside the USA. Typical Apple.
I asked my doctor at UCHeart today. His words, exactly, "I wouldnt rely on that thing for the life of me". He stated "studies show only a 50% accuracy compared to hospital machines and that he or any other responsible Cardiac doctor could not endorse these miniature 1 lead units until accuracy is addressed. He also stated it would he fine to use for a baseline for exercising but not much else".
Who's to say they didn't do that? Just because it isn't approved on launch doesn't mean it hasn't been in process.
Your approach to this is hyperbolic. You and others are acting as if the FDA gave some type of hand-wavy approval of this product. Apple is not going to release the feature without FDA approval.
FDA approval
FDA approval
FDA approval
Not Apple magic, fairy dust approval. FDA approval.
You do not work for the FDA. You are not one of the doctors who worked on the testing for Apple. You are not privy to all of the data that was analyzed, nor are you qualified to analyze it.
You are playing armchair doctor/analyst based on the very limited public information that is available about this.
We, on the other hand, are putting our trust in the same agency that is responsible for approving the 10 and 12-lead devices that you seem to have no problem with.
Yes things can vary from one hospital to another unfortunatly
Still it will be interesting in the US when it goes live. If that many US users go to their doctors because of their AW then premiums may increase or even worse an exclusion clause. I understand the average ECG test is about $45 but the guy to read the results can be anywhere between $100-$800
As most may consider this to be more of a gimmick it's a shame its not a lie detection instead but then it would be worn by very few Apple employees
You're taking a poorly informed, conjecture based article and interpreting it as fact which isn't wise. There's nothing 'typical Apple' about it. It's a process, applied equally to Apple just like it is to Medtronic, BD, BSC... the quite remarkable thing here is that here we have a consumer company stepping up to 21CFR820, MDD and beyond.
KGB7 said:
Welcome to the medical community. There's studies countering each other constantly. There's been studies that these devices are highly accurate and I've discussed this in the ED with doctors who think this is a great thing back when AliveCor started offering devices and they'd back it as a benefit.
I'm honestly not surprised your doctor said he wouldn't rely on it, doctors make the worst patients.
My libertarian philosophy applies to all aspects of life as it pertains to our interaction with the State. You think the free market wouldn't create regulatory agencies? How do you explain the creation of Underwriters Laboratories?
Atrial Fibrillation is believed to be greatly under-diagnosed given its sporadic in nature, especially during early to middle age. Even in older people, like myself, it's very hard to capture and diagnose given the occurrence rate is too low to be reliably picked up by routine ECG tests. People experiencing mild atrial fibrillation often are unaware of it.
Yet this disorder has a high correlation to strokes later in life. Your first indication of a problem could be a disabling stroke.
The beauty of the Watch Series 4 (when the software arrives) is that it potentially can monitor you 24x7, and as a result will eventually detect when AF occurs, even if it's very sporadic or related to certain activities. (Assume for the moment that sex is what trigger's your AF... kind of hard to capture that moment in the doctor's office. Or only when you're hiking up a steep hill. Or having a strong emotional reaction to something.)
The challenge then is to get your cardiologist on board. The problem is exponentially worse if you don't already have a cardiologist that you see. I'm not aware of a standard stress test that can be used to reliably reveal the problem.
Some docs will embrace the opportunity for 24x7 monitoring, and others will be less receptive. That might depend on how they get paid (in the US anyway).
For my part, as soon as the software is available, I'm going to be talking to my cardiologist about how to get him plugged in. Assuming he's not already welcoming this feature.
The difference in the US versus the UK is that docs in the US have significantly more freedom in how they respond to new technology, given that healthcare in the US is mostly a private business and docs can set their own rules (within reason).
That said, it will be interesting to see how private insurance handles compensation for doctor visits triggered by the Watch. Preventing a stroke by detecting AF and treating it early (with meds) is a LOT cheaper than treating the patient after a stroke, so likely they'll view this as a good investment. Insurance in a free market environment is always looking at the lowest total cost of treatment.
Yet this disorder has a high correlation to strokes later in life. Your first indication of a problem could be a disabling stroke.
The beauty of the Watch Series 4 (when the software arrives) is that it potentially can monitor you 24x7, and as a result will eventually detect when AF occurs, even if it's very sporadic or related to certain activities. (Assume for the moment that sex is what trigger's your AF... kind of hard to capture that moment in the doctor's office. Or only when you're hiking up a steep hill. Or having a strong emotional reaction to something.)
The challenge then is to get your cardiologist on board. The problem is exponentially worse if you don't already have a cardiologist that you see. I'm not aware of a standard stress test that can be used to reliably reveal the problem.
Some docs will embrace the opportunity for 24x7 monitoring, and others will be less receptive. That might depend on how they get paid (in the US anyway).
For my part, as soon as the software is available, I'm going to be talking to my cardiologist about how to get him plugged in. Assuming he's not already welcoming this feature.
The difference in the US versus the UK is that docs in the US have significantly more freedom in how they respond to new technology, given that healthcare in the US is mostly a private business and docs can set their own rules (within reason).
That said, it will be interesting to see how private insurance handles compensation for doctor visits triggered by the Watch. Preventing a stroke by detecting AF and treating it early (with meds) is a LOT cheaper than treating the patient after a stroke, so likely they'll view this as a good investment. Insurance in a free market environment is always looking at the lowest total cost of treatment.
Not how things work in the EU. You can’t write off responsibility with disclaimers, especially when you get into medical devices as they have certain regulation.
The good news is that you can get this at EU-level and not have to go through all regulations in every member country.
Hi, welcome to our planet. Perhaps you would be interested in buying the Tower Of London, which has recently come into my possession?
Seriously? Have you ever met "People"? OF COURSE some people will use this instead of going to the doctor, and ignore their chest pains and dizziness if the watch says they're OK. Other people will rush to the doctor every time the watch bleeps and demand medication - at best, wasting time and money. You can't solve people but you can insist that products making health claims are reliable - not just take the word of the company that wants to make loadsamoney selling them.