The new Apple Watch 4 has an electrocardiogram function (ECG or EKG) that is "erased". but not approved by the Food and Drug Administration (FDA).
Having this stamp of approval gives the consumer confidence in the product, but has limits that do not apply to products that are approved by the FDA, the true gold standard regulator.
Apple's health technology has authorization from the FDA for people over 22 to use it, but, technically, no one younger should have the device.
In addition, the Apple ECG is not designed for people who have been diagnosed with atrial fibrillation, the group with the highest risk of heart rhythm abnormalities that the function aims to detect.
The public – and those loyal to Apple around the world – are so enthusiastic about the new technology "because they know nothing about the science of disease screening in a population with a very low prevalence of that disease," says Dr. David Brown, Cardiologist at the University of Washington, San Luis.
Jeff Williams, Apple's chief operating officer, introduced the EKG feature of Apple Watch 4 to the hype and cymbal, but cardiologists are not so convinced of the feature they fear it will yield false positives.
An electrocardiogram is a crucial diagnostic tool for heart disease and arrhythmias.
In a hospital or clinical setting, the test monitors the electrical activity of the heart through electrode sensors placed on the chest and sometimes on the extremities.
It is also the diagnostic tool for doctors who respond to an alleged heart attack.
And now, the FDA has approved it as part of a fashionable portable device for anyone, as long as it is over 22 years old and does not have the most common heart rhythm problem.
The previous Apple Watch mode was already equipped with a heart rate monitor that keeps track of the user's usual heart rate during various activity states and notifies them if something is turned off, given the activity they seem to be doing.
The evaluation sounds good, but in reality it is part of this "quantified of itself" movement misunderstood
Dr. David Brown, cardiologist at the University of Washington in St. Louis
And in December 2017, the FDA approved KardiaBand, a supplement to the device that gave it the ECG capabilities.
Now, that technology is completely integrated into the original Apple watches.
And people are very excited about that, as was evident by the applause, applause and applause that erupted the moment Apple COO pronounced the word & # 39; electrocardiogram & # 39; on stage at the company's event on September 12.
Notably, atrial fibrillation is a problem of old age, increasingly common in people between 60 and 70 to 80 years old, and so on.
"I do not know too many 80-year-olds who want or have Apple watches, they are the 30-year-olds who are generally healthy and rich who use an unproven device for atrial fibrillation," says Dr. Brown.
Their risks are so low, but monitoring is so constant, that they worry that there will be an increase in false positives of the new Apple watches.
You can imagine that a 30-year-old boy, on a Saturday night, receives a notification from the Watch [to take an ECG]He searches on Google and discovers that they are at risk of having a stroke, "says Dr. Brown.
"They will end up in a clinic or emergency room, distract doctors from patients who need attention, undergo unnecessary exams, and then they are told to go home because nothing happens."
The studies, including one from Stanford University, which has now partnered with Apple for a continuous cardiac study, have shown that the device is 98 percent accurate.
But the watch will only tell a user to take an ECG if Apple's heart rate sensors detect unusual activity.
Although there have been reports that the earlier and simpler cardiac monitor saved the lives of people who did not realize they had heart failure, there are also many false alarm accounts.
I do not know too many 80-year-olds who want or have Apple watches. They are 30-year-olds who are generally healthy and rich who use an unproven device for atrial fibrillation.
For example, the final moments of last year's NFL playoff game between the Minnesota Vikings and the New Orleans Saints were so dramatic that the heartbeats of couch fanatics across the country suddenly went from slow to constant to fast. and erratic, unleashing everything you see bells and whistles.
Those fans, of course, were not in medical trouble, simply in emotional distress or euphoria, depending on who they were cheering for.
And even if the sensors are incorrect one or two percent of the time, that could mean false positives for many people, Dr. Carter said.
The Stanford study involved fewer than 600 patients. Last holiday quarter alone, Apple sold eight million watches. If they had the new watch, and only one percent of them gave false positives, that would still be 80,000 people making emergency trips to the emergency room, unnecessarily.
"The evaluation sounds good, but it's actually part of this movement of" quantified complacency "misunderstood," says Dr. Brown.
& # 39;[The Apple Watch] it is not tested in terms of its effect on any type of health outcomes; it's just that the device and its algorithm work. "
That is the essence of what it means to have authorization from the FDA, but not approval.
The device is safe, does what it says with reasonable accuracy, but that does not mean the FDA is confident it will reduce the rate of cardiac arrhythmias among Americans.
However, "it's a seal of approval from the perspective of a layman's device," says Dr. Brown.
"They're going to see that, and the president of the American Heart Association supports this as a way to potentially improve health outcomes without any data, and it would be foolish to believe that those two things will help them."
Add that you're saying & # 39; that the new Apple Watch is not erased, let alone approved, to be used by people who have already been diagnosed with atrial fibrillation.
"Does Apple not want the responsibility of using your device on people who have a much higher risk? If you are so sure that it is more than 98 percent accurate, you would think they would want it to be used on people at risk of problems." says Dr. Brown.