Is the Apple Watch Series 4 with ECG Fake News?
Well, in one word, yes; in more than one word, I honestly think so!
Why would Apple, one of the greatest companies of this millennia degrade itself and go with a 1-lead ECG “watch gadget” and not a top of the line 12-lead that would have changed the face of healthcare for years to come. It would have also kicked out all its competitors from the rat race. While 12 leads is “real medical,” 1 lead is not even “healthcare.” With the massive amounts of potential “false-positives,” they are bringing increased burdens and longer waiting lists – preventing “truly sick” patients from receiving immediate attention. While Apple claimed and argued that the Series 4 ECG was a great step forward in home healthcare, most critics are saying that many people will understand that they have problems when they don’t have any and then rush off to the hospital or physician. In fact, the June 2018 US Preventive Services Task Force[1] concluded that the evidence fails to show this approach does more good than harm.[2]
But, the real fake news is the FDA claim. Apple stated (correctly) that the FDA granted Apple a “de novo” request for classification. What does that mean? Does that mean that the Apple ECG is FDA granted? No! All Apple received was a pre-clearance, rather than a full approval with the device being classified as an “over the counter” Class 2 device, the same as a pair of crutches, powered wheelchairs and some pregnancy test kits. So how rigorous were the tests conducted by Apple? While most medical companies spend years testing their products on thousands of people, Apple informed the FDA that for their ECG they only reviewed data from 588 people, about half of whom had permanent or persistent AFib. The app wasn’t able to classify about 1 out of every 10 rhythm recordings. All this means (in reality) that the Series 4 did not undergo rigorous testing nor clinical trials.
The question that needs to be asked is why didn’t Apple join forces with some of the unique startups that have brought to market real FDA 12-lead ECG devices? Companies like HealthWatch Technologies who have a full 12-lead ECG washable garment (www.healthwatchtech.com) or even Labtech (www.labtech.hu) and others.
All the Series 4 is, and will be, another 1-lead gadget on the market that monitors (maybe) ECG! If it is as accurate as the Apple 2 heart rate monitor, we, as netizens, have a lot to worry about!
