That’s the question many are asking, and according to some experts, the answer is ‘no.’ Now, you may ask ‘why?’ And the answer lies in the reputation of a company like Apple, who decided to go with a 1-lead ECG watch and not a top of the line 12-lead. Why would apple do that? While 12 leads is considered to provide “real medical” data, 1 lead is not even “healthcare.”
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The massive amounts of potential false positive results bring increased burdens and longer waiting time, preventing patients who are really sick from getting immediate medical attention.
The June 2018 US Preventive Services Task Force concluded that the evidence fails to show this approach does more good than harm.
For adults at low risk of cardiovascular disease (CVD), the US Preventative Services Taskforce (USPSTF) recommends against screening with resting or exercise electrocardiography (ECG) to prevent CVD.
“In all risk groups, an abnormal ECG finding (a true-positive or false-positive result) can lead to invasive confirmatory testing and treatment that have the potential for serious harm, including unnecessary radiation exposure. Two studies of asymptomatic adults with diabetes reported that 6% and 12% of patients who were screened with exercise ECG subsequently underwent angiography, and 3% to 5% underwent revascularization, without evidence of benefit to the study patients.1, 2 Angiography and revascularization are associated with harms, including bleeding, contrast-induced nephropathy, cardiac arrhythmia, stroke, myocardial infarction, coronary artery dissection, allergic reaction to the contrast agent, and death,” said USPSTF.
Now, let’s look at the ‘real fake’ news, and that’s the FDA claim. According to Apple, the FDA granted the company a “de novo” request for classification. That means Apple only received 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, did Apple go through rigorous tests like the ones conducted by most medical companies? Well, Apple told the FDA that for their ECG they only reviewed data from 588 people, about half of whom had permanent or persistent AFib.
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Now, the question 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.
For now, all the Apple Watch 4 is, just another 1-lead ECG reader on the market that monitors ECG. If it is as accurate as the Apple 2 heart rate monitor, we have a lot to worry about!
