Thanks for the heads-up. Your views can then be safely ignored on this matter.
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Apple Watch Chief Jeff Williams Says ECG App is 'Huge Opportunity' to Empower People About Their Health
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Thanks for the heads-up. Your views can then be safely ignored on this matter.
It was not approved as a medical device.
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I agree.
I'm just happy no-one said no warring is better than some warning. (only they did).
You have to be kidding yourself if you think having something of a monitor is a bad idea. We can't go around wearing 12 lead monitors and keep ourselves surround in test gear. If something as small as a watch, which does many other things by the way, will offer something then dang how can someone be upset. They waited until version 4 for a feature many thought should have been in version 1 just so they could get it as right as they could. Now with FDA clearance I have to think they are pretty close.
You have to be kidding yourself if you think having something of a monitor is a bad idea. We can't go around wearing 12 lead monitors and keep ourselves surround in test gear. If something as small as a watch, which does many other things by the way, will offer something then dang how can someone be upset. They waited until version 4 for a feature many thought should have been in version 1 just so they could get it as right as they could. Now with FDA clearance I have to think they are pretty close.
What about those who rely on the false negatives and NOT see a doctor?
No one should ever skip a doctor's visit. Ever. Most of them are planned, and if heart disease is not in your mind you won't go see a cardiologist until either your physician tells you so or until you feel something is wrong. In other words, not having a monitor tool - as simple as it can be - IS a false negative by definition, until pain or discomfort occurs.
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Jeez! Are you a pro-athlete???
Aren't you supposed to take the EKG before the watch diagnoses the Afib?
A friend of mine with an Apple Watch noticed that his heart rate is in low 40s, and also freaked out. Also went to see a cardiologist. Nothing was wrong.
We are talking about a simple heart-rate monitor here. Imagine what is going to happen with the EKG feature.
My heart rate at night is in the mid-40s. A few times it was in the upper-30s. I knew it because I wear the Apple Watch in bed. It freaked me out completely. The doctor said it's normal. Nothing to worry about.
A friend of mine with an Apple Watch noticed that his heart rate is in low 40s, and also freaked out. Also went to see a cardiologist. Nothing was wrong.
We are talking about a simple heart-rate monitor here. Imagine what is going to happen with the EKG feature.
And what is your problem with this? You have no medical backing or anything to support your absurd claims. Educate yourself please.
https://www.theverge.com/2018/9/13/...es-4-ekg-fda-approved-vs-cleared-meaning-safe
The Apple Watch is in Class II. For Class II and Class I, the FDA doesn’t give “approval,” it just gives clearance. Class I and Class II products are lower-risk products — as Speer puts it, a classic Class I example is something like a tongue depressor — and it’s much easier to get clearance than approval.
Most of the time, products are cleared because they’re sufficiently similar to an existing medical device that the FDA already regulated. Apple, however, has emphasized that it has received a “de novo” classification for the EKG feature. That means that, although it’s still in Class II in terms of risk and hasn’t gone through as much testing as an “approved” device, it’s unlike anything else on the market. It is the first direct-to-consumer EKG wearable. (Last year, the FDA approved the AliveCor KardiaBand, a watch accessory that essentially does the same thing, but that wasn’t direct-to-consumer.)
Historically, claiming something is “de novo” is a less common way of getting devices to market, but it’s becoming more popular, adds Speer, as we blend fitness gadgets with emerging technology. “We’re going to continue to see these wearable technologies cross over and become regulated as medical devices,” says Speer. “Think about things that are indicators of your health: blood pressure, heart pressure, respiratory rate, maybe things like diabetes management. The possibilities seem endless.”
As just one example, Omron has been working on a blood pressure monitor that looks like a smartwatch. Last year, the European Union announced that the Natural Cycles fertility-tracking app can be classified as a medical device. (This may not have been a wise decision, given the controversy around the app.)
That more people will finally go to see a cardiologist. Finally. Considering the obesity rate in the US, this is a good thing.
That's my HR in the middle of workout. How am i supposed to use it if it can't tell how physically fit the person is.
Agree. One thing Apple Watch has done is wake owners into taking more interest and care of their health. The actual technology might not be a silver bullet for 100% accuracy, and once we plateau in the number of people willing to buy an Apple Watch, the pressure is on Apple to start increasing the accuracy.
People also seem to be missing key points here: 1) you only get the warning following a sustained and prolonged run of negative indicators and 2) the Watch only recommends that you 'may' wish to contact your Doctor. It's not glowing and shouting that you'll die with five minutes.
As much as I despise Tim Cook and Apple in general at the moment, I really appreciate my Apple Watch and the impetus it has given me to seek out new information about my health and the encouragement it gives me to at least ensure I meet the recommended minimum activity each day. And you know what? I do feel a tiny bit better for it.
You can disable low heart rate notifications or set a lower threshold in the Watch app under Heart if the notifications are triggered for HRs that aren’t out of the norm for you.
Ahaha. Doctors get richer, become more crowded and for those that really need an appointment, harder to get in quicker.
Good, demand will go up and we'll have more kids trying to get into a medical degree instead of a gender studies one.
If 48 is your heart rate in the middle of a workout, I would suggest getting a real heart-rate monitor (not the one in the Apple Watch) and monitor your heart rate while you are working out. I bet it's the Apple Watch that is giving your inaccurate readings. Personally, I think the Apple Watch heart-rate monitor is extremely inaccurate and unreliable. I've had four Apple Watches so far, with the latest one being Series 3, and none of them can reliably detect heart-rate during exercise either for me or for my wife.
Another thing you can do is buy a bluetooth heart-monitor strap and connect it to your Apple Watch. You may get a better accuracy this way.
Now, if your heart rate really turns out to be 48 during a workout, I would suggest you see a cardiologist.
I think this move to health is a huge mistake. Apple is going to be seen as a health warning product line, which is not cool. It is terrifying, Will it also detect body odor, farting, cancer? The body for the most part is ugly and nobody wants to hear bad news. Also other companies will come up with the same individual functions and charge $ 50. Making Apple look overpriced by a factor of 10.
Apple today announced that its ECG app will be available on the Apple Watch Series 4 today as part of watchOS 5.1.2. Alongside that news, TIME has published a new interview with Apple's CEO Tim Cook and COO Jeff Williams.
The article begins with a story about 46-year-old Texas resident Kevin Foley, who was having trouble breathing normally during a movie. Fortunately, since he was wearing an Apple Watch and participating in the recent Apple Heart Study, he was alerted to signs of an irregular heartbeat and went to the emergency room.
At the hospital, doctors hooked Foley up to an ECG machine and found signs of atrial fibrillation, an irregular heartbeat that can lead to stroke and other potentially fatal complications. Foley spent the next few days in the hospital while doctors worked to return him to a normal sinus heart rhythm and is doing fine now.
"Apple's largest contribution to mankind will be in improving people's health and well-being," Cook boldly proclaimed.
"We have tens of millions of watches on people's wrists, and we have hundreds of millions of phones in people's pockets," said Williams. "There's a huge opportunity to empower people with more information about their health. So this is something we view as not only an opportunity, but a responsibility of ours."
Williams also appeared on CBS This Morning today to talk about the ECG app. The YouTube video can only be streamed in the United States.
The report says a traditional hospital ECG is often referred to as a "12-lead" machine, as its 10 different electrodes provide information on 12 different areas of the heart. The new Apple Watch is the equivalent of only a single-lead device, but research suggests the ECG app is still very accurate.
In a press release, Apple said the accuracy of its ECG app was validated in a clinical trial with around 600 participants. The study found the ECG app on Apple Watch demonstrated 98.3 percent sensitivity in classifying atrial fibrillation:"The FDA has been very rigorous, and they should be," said Williams, referring to the Apple Watch's heart health features.
The article goes on to claim that some cardiologists and other experts have raised concerns that the Apple Watch's ECG feature is "unnecessary for the general population" and "could cause problems," including false positives.
"If everybody with an Apple Watch and an alert from an Apple Watch went to a heart-rhythm doctor that was super comfortable with this, then I think it would be O.K.," said Dr. John Mandrola, a cardiac electrophysiologist. "But there are going to be millions of people going to the doctor that in many cases will be just fine."
Apple responded that no medical test is 100 percent accurate, so some false positives are inevitable, according to the report. Moreover, the Apple Watch will only alert users to a potential heart-related problem if it detects five instances of what it considers a cardiovascular episode, including arrhythmia.
Importantly, in an internal document obtained by MacRumors, Apple cautioned that the ECG app is "not intended to be a diagnostic device or to replace traditional methods of diagnosis," and "should not be used to monitor or track disease state or change medication without first talking to a doctor."
To take an ECG reading from the Apple Watch, users will need to place a finger on the Digital Crown while wearing the watch. The reading is completed in 30 seconds, allowing users to determine whether their hearts are beating in a regular pattern or if there are signs of atrial fibrillation.
Irregular heart rhythm notifications will also be available on Apple Watch Series 1 through Series 4 models in watchOS 5.1.2.
Apple says the setup process for these heart health features will include details about who can use the features, what the features can and cannot do, what results users may get and how to interpret them, and instructions for what to do if users are feeling symptoms that require immediate medical attention.
watchOS 5.1.2 should be available through the Apple Watch app on a paired iPhone around 10:00 a.m. Pacific Time as usual. At launch, the ECG app will be limited to the U.S., but Apple is likely working to get regulatory clearance elsewhere.
Article Link: Apple Watch Chief Jeff Williams Says ECG App is 'Huge Opportunity' to Empower People About Their Health
There will also be some lawsuits with dead children who depended on their watch for opinions and didn't run to the hospital and the juries will know Apple is worth a trillion.
This whole thing could have been done in the 50's by putting an ECG on top of the 100 pound computer monitor ... so what if the whole thing was 140 pounds, you had to sit in front of it all day anyway, no?
And since we'll have and need plenty of doctors we can implement the free Education and Health Care for all programs All Americans deserve. Win win for all
Which means we'll have money to pay for education and educators, so Americans will become true intellectuals.
Super win win for all, all because of the EKG function of the Apple watch!!!
Did it really tell you to "seek help" or did it say the recording was uninterpretable??
A below-normal rate like that is called bradycardia. It is normal in many patients, especially athletes, but it can be evidence of an arrhythmia too. Part of the value of having a device like this (I've been a Kardia user for 2 1/2 years) is that it allows you to know what your normal range is, both resting and exercising.
Haha, how should that work ... attack is something not really foreseeable ... that’s the inherent nature of an heart attack.
You wanna have none, live healthy, even then no guarantee
The haters are out in full force today. Just a hint of anything positive for Apple and they come out it droves. How is this feature not a cool thing to have?