C’mon this is the country that has no idea of what the Hell to do at the end of March next year ;-)
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ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom
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I have used a just a limb lead before as a tool just to assist in confirming ROSC. Yes the leads goes right on the patients wrist. Normally our limb leads go on wrists and ankles though they can go a little more central on the extremities (by each hip bone and on each shoulder) and still provide a fine read.
The Wording in the Article Quote uses the words" You may need to carry out" , instead of "Must Need or are Required". May and Must are very different. Perhaps the UK will approve the Watch4 for what it is and how it might actually help people to know they need the MD's Services.
The Watch4 I bought was too small; so, I have returned it to Apple and will get the larger one. Unfortunately the Cardiology Software was not released ; so, I could not evaluate it completely. The W4 is very powerful. A single chip inside a beautiful package. Amazing work on the part of Apple. The ability to call and hear on the watch better than I can on my iPhone was wonderful. Text messaging - Wonderful.
The Information software buttons are a little small for my fingers and eyesight ; so, that is why I want a larger W4. I was too far from a store to try the W4 on , but even with my smaller wrists and arms I think the Larger one would be best for me.
The Watch4 I bought was too small; so, I have returned it to Apple and will get the larger one. Unfortunately the Cardiology Software was not released ; so, I could not evaluate it completely. The W4 is very powerful. A single chip inside a beautiful package. Amazing work on the part of Apple. The ability to call and hear on the watch better than I can on my iPhone was wonderful. Text messaging - Wonderful.
The Information software buttons are a little small for my fingers and eyesight ; so, that is why I want a larger W4. I was too far from a store to try the W4 on , but even with my smaller wrists and arms I think the Larger one would be best for me.
It's nothing to do with being paternalistic, it's about money. The problem is, if it started to give a large number of false readings, then it could potentially overwhelm the already overstretched national health service, which is publicly funded. They want to make damn sure a device isn't going to end up extending waiting lists and costing a fortune in unneccesary testing.
Having been in the biotech/pharma industry many good ideas go by the wayside due to regulators, lack of vision of BOD or the potential of profits.
If this feature proves to have serious issues it can be turned off.
Apple just needs to determine how much the pockets of the regulators across the pond can hold
[doublepost=1538059310][/doublepost]
If this feature proves to have serious issues it can be turned off.
Apple just needs to determine how much the pockets of the regulators across the pond can hold
[doublepost=1538059310][/doublepost]
And has webMD been blocked?
The FDA warns that Apple's ECG app is not designed to replace traditional methods of diagnosis or treatment and is intended for informational use only. The Series 4 is the first ECG product being offered over the counter directly to consumers.
Article Link: ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom
Are you trying to provoke the wrath of Vic Gundotra?
https://daringfireball.net/linked/2018/09/14/gundotra-cue-the-worlds-tiniest-violin
When it’s works in the UK, I’ll upgrade from my Nike Series 2.
Is this feature really the only reason you can see to upgrade to a Series 4?
Don't hold your breath
I really don't understand posts like this. People aren't going to use the ECG feature of the Apple Watch in lieu of going to the doctor. The entire point of it is that we do not go to the doctor every day. Most people don't even go once per year. The importance of this device is that, if needed, it will trigger people to make that appointment with their doctor or head to the emergency room and receive treatment that they otherwise wouldn't have received. It isn't about this being less accurate than what is available at a hospital. It is about it being way more accurate than nothing at all.
I was going to respond until I read your response. You hit the nail on the head. I'm not sure the phrase "wildly inaccurate" means what Khedron thinks it means (Princess Bride reference).
Out of interest, do you go to the doctor's office every day to have an ECG done?
Once per week?
Once per month?
Every six months?
Once a year?
The Apple Watch Series 4 will be able to provide you information for the 300+ days per year when you are not in a doctor's office getting the 12-lead ECG. Furthermore, most people do not even have an ECG test during their annual doctor's visit. The problem is that it is often too late when people realize they need these tests. Have you never seen the ads that talk about the warning signs for heart attack and stroke? The Apple Watch is no less accurate than watching for those signs. The difference is, people are more likely to check on themselves with this cool piece of technology.
Would you rather have an inaccurate reading that sent you to the doctor to find out you are okay or no reading for the time when you were having an actual issue? That is what you are advocating for by poopoo-ing the Apple Watch. Stop trying to compare it to the 12-lead ECG. Compare it to what is being used now, nothing.
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Doesn't that just mean looking for the existence of a heartbeat? Apple are making far greater claims than just that.
No, in the UK (and in the EU) there are regulations to follow for a good reason. Consumer (patient) is more important than business.
Warning people won't keep them from overloading the emergency services and healthcare system with false positive situations. And that's why this device needs proper testing, so that its readings are interpreted correctly...
Well you aren't going to self-treat a cardiac arrythmia, so I'd hope you'd see a doctor anyway.
However, there are two potential probems with a device like this. False positives, which cause unnecessary anxiety and divert healthcare resources from those with greater need, and false negatives, where someone who has a real problem is false reassured because the device doesn't detect it. Most posts have concentrated on the first, but the second is obviously more serious for the individual. This is why even with disclaimers you need an approval process for devices like this (and even after approval, assuming it succeeds, this will need a disclaimer).
Yeah, just forgot there is a public health system in the UK.
Nevertheless I'm quite sure you'd be yelled out of a public UK hospital if you got to the ER and told them your Watch said you're having an attack.
The accuracy of the actual device under different conditions, on different watches (product consistency) over time.
NHS just gave me check up schedule 3 months for a test because I am having pain. My doc advises me to take pain medication till then. Wondering what will happen to my kidney if i follow them. People are nice in NHS. But it is run by some pretty incompetent government people who controls the funding and general direction.
One finger EKG? Ha-ha.
When I get an EKG at my doctor's office, about 10 electrodes are attached at various points of my body - near the ankles, wrists, upper arms and chest.
When I get an EKG at my doctor's office, about 10 electrodes are attached at various points of my body - near the ankles, wrists, upper arms and chest.
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Yes, return of spontaneous circulation. I was answering directly based on your question so apologies if I mislead you You can interrupt an arrhythmia with a single lead and we have our limb leads laid out so we can do a primary assessment in non-cardiac and cardiac suspected calls that don't have major signs and symptoms of an issue with just those before diving further into a full 12 lead printout though an initial 12 lead is being pushed more and more in the community to help find the off chance something may have something going on that's been unrelated to what we show up for. And this is exactly what Apple has been following into (AliveCor got their attention about it) so that people who don't even know they have an arrhythmia can find out and seek proper treatment.
Edit: In summary a single or two lead can save setup and embarrassment (old women really don't like you lifting their shirts, no surprise) of a non-eventful patient so that transport and initial care can take priority while covering any underlying issues that may have been related after all but could potentially get missed even at the ED where the nurses decide not to apply monitoring. Surprise MI's are a very real and dangerous thing.
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Is this feature really the only reason you can see to upgrade to a Series 4?
Don't hold your breath
I really don't understand posts like this. People aren't going to use the ECG feature of the Apple Watch in lieu of going to the doctor. The entire point of it is that we do not go to the doctor every day. Most people don't even go once per year. The importance of this device is that, if needed, it will trigger people to make that appointment with their doctor or head to the emergency room and receive treatment that they otherwise wouldn't have received. It isn't about this being less accurate than what is available at a hospital. It is about it being way more accurate than nothing at all.
I was going to respond until I read your response. You hit the nail on the head. I'm not sure the phrase "wildly inaccurate" means what Khedron thinks it means (Princess Bride reference).
Out of interest, do you go to the doctor's office every day to have an ECG done?
Once per week?
Once per month?
Every six months?
Once a year?
The Apple Watch Series 4 will be able to provide you information for the 300+ days per year when you are not in a doctor's office getting the 12-lead ECG. Furthermore, most people do not even have an ECG test during their annual doctor's visit. The problem is that it is often too late when people realize they need these tests. Have you never seen the ads that talk about the warning signs for heart attack and stroke? The Apple Watch is no less accurate than watching for those signs. The difference is, people are more likely to check on themselves with this cool piece of technology.
Would you rather have an inaccurate reading that sent you to the doctor to find out you are okay or no reading for the time when you were having an actual issue? That is what you are advocating for by poopoo-ing the Apple Watch. Stop trying to compare it to the 12-lead ECG. Compare it to what is being used now, nothing.
All I'm advocating is that Apple follow the established procedures for health devices. You seem to think they deserve exemption from the law because they are sufficiently "cool"?
The years of regulatory testing are in place precisely to protect people that believe tweets hold any value or legitimacy.
And for those who have an avoidable heart attack because their gadget said they were OK and so they didn't visit a doctor?
If they're asymptomatic they wouldn't go anyways. If they do have chest pain and don't go, then thats darwinism.
Earlier this month, Apple unveiled the Apple Watch Series 4 with a new electrocardiogram (ECG) feature that measures the electrical activity of your heartbeat, providing you with a heart rhythm classification that can be shared with your doctor. The feature isn't out yet, but it will be limited to Series 4 models in the United States later in 2018.
Today, 9to5Mac shared a potential time window for the launch of the ECG feature in the United Kingdom. The Medicines and Healthcare products Regulatory Agency (MHRA) explains that the process starts by examining Apple's documentation surrounding the ECG feature and performing an audit of the quality assurance system.
While this step doesn't appear to be lengthy, the proceeding steps could make the process longer. MHRA says it would require Apple to perform a new clinical investigation to judge the effectiveness of the ECG on Apple Watch, but Apple would likely not be able to use any of the data from the studies it's already completed because MHRA requires companies to notify the regulator in advance of a study.
Once the study is submitted, MHRA has 60 days to approve it (which may become longer if the regulators have further inquiries for Apple), and then Apple can begin the study. These last few steps are what the MHRA say "could potentially add years" onto the debut of the ECG in the UK.
Despite the potential for years-long approval, Apple may find ways to expedite this process. While the United Kingdom remains part of the European Union, it's possible that Apple could receive approval from a broader regulatory body and sidestep the MHRA's processes.
In the United States, Apple has obtained de novo FDA clearance for the ECG feature in the Apple Watch Series 4 and the feature that can send a notification if an abnormal heart rate has been detected. However, FDA clearance is not the same as FDA approval and the FDA does not recommend that the ECG feature be used by those under 22 or those who have already been diagnosed with atrial fibrillation.
The FDA warns that Apple's ECG app is not designed to replace traditional methods of diagnosis or treatment and is intended for informational use only. The Series 4 is the first ECG product being offered over the counter directly to consumers.
Elsewhere, Apple has said it is working with Health Canada to bring the ECG functionality to the Canadian market, although no timeline has been specified.
Article Link: ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom
And so the battle begins... Unless, there is a faster way to approve such kind of features on devices like AW, mass adoption throughout the world will take years. Remember, ECG is only the beginning, as we should expect more and more advanced medical features to arrive on our smartwatches in the near future.
Getting a medical device cleared is not trivial but this article is flat out wrong and uninformed. Clinical data from the US can and is regularly used for clearance in Europe. Technical files are produced directly from US design history files with a few basic changes and CE is actually a lower bar for various reasons not topical here. Apple will certainly already have a notified body in the UK and are in process. Whoever wrote the article isn't in the medical device business, but did perhaps stay at a Holiday Inn Express last night.
You are correct, this is simply a lame bureaucratic maneuver and/or usual Euro protectionism
Well, I'm not surprised that governments that control healthcare would not like the Apple Watch ECG.
Just another benefit of government controlled universal healthcare. The best preventive care... last.
Just another benefit of government controlled universal healthcare. The best preventive care... last.