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New Apple Watch is an FDA-approved medical device
02:38 - Source: CNN

Editor’s Note: Ford Vox is a physician specializing in rehabilitation medicine and a medical journalist. He writes frequently for CNN Opinion. Follow him on Twitter @FordVox. The opinions expressed in this commentary are his. View more opinion articles on CNN.

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Apple unveiled a medical device this week, complete with FDA approval. This device – the Apple Watch Series 4 – is unlikely to be reimbursable on your insurance plan, but maybe it should be. It could very well save lives.

The core advancement is a darling of a med tech smart set that touts the coming democratization of medicine. It’s an electrocardiogram app. A company called AliveCor, backed by tens of millions in venture capital, is already marketing a similar ECG app that requires connecting peripheral sensors to your Apple Watch or iPhone. The sensors range in price from $99 to $199, followed by monthly or annual fees. AliveCor got excellent PR on its road to market when one of the country’s most famous cardiologists, Dr. Eric Topol of Scripps Research, used the device to diagnose atrial fibrillation in a woman on a United Airlines flight.

Now Apple is incorporating ECGs into the Apple watch’s native software and hardware, a move that must temper AliveCor’s investors, but such usurpation is a known risk in an industry where platforms routinely push around, and push out, their developers. That said, AliveCor appears more clinically robust, producing ECG strips doctors can upload into electronic medical records, along with clinical worksheets doctors can use to interpret and sign off on, and even bill for their work.

With electrodes built into the watch’s “digital crown” and its native ECG rhythm analyzer, the Apple Watch will now inform you if your heartbeat warrants medical attention. There are many abnormal rhythms Apple’s watch can’t detect, but most of the attention is on atrial fibrillation: it’s common and potentially deadly.

Atrial fibrillation develops in 2%- 3% of us over the course of our lifetimes, sometimes without any symptoms or with very vague symptoms (like a touch of light-headedness). When the upper chambers of the heart (atria) beat irregularly, blood doesn’t move through the heart in the manner it should. This can leave some blood moving slowly enough that it congeals into clots. When those clots move out of the heart and block one or more arteries in your brain, they can cause a debilitating stroke.

Your heart can go in and out of this rhythm, so an annual physical, including an ECG, can easily miss it. Of course, Apple’s software only offers a single lead. A full ECG has 12 leads and is necessary to diagnose a whole host of other heart conditions.

I’ve seen this scenario dozens of times in my role as a neurorehabilitation physician, helping patients at the Shepherd Center in Atlanta recover as much brain function as possible after these types of strokes. In the vast majority of cases I’ve seen, my patients got no warning their heart had a bad rhythm (arrhythmia). Their first symptom wasn’t heart palpitations; it was paralysis.

An editor at CBS’ tech news site ZDNet managed to prevent such an outcome for himself by trying out an earlier version of Apple’s heart app this year. After enrolling in a large Apple research and development study, Jason Perlow saw an alert pop up about his irregular heartbeat, leading to his diagnosis. He’s now undergoing treatment for atrial fibrillation.

Such treatments can be serious, including the use of blood thinners and invasive heart procedures. And that’s where the potential harm of all this new surveillance comes in: With screening on such a massive scale, will some people get diagnosed and treated for atrial fibrillation that may never have caused a stroke or other serious problem?

Doctors contemplating blood thinners will compute a patient’s risk score, based on features like age and history of related health conditions, such as diabetes or high blood pleasure. But there’s debate over what score equals what treatment. The “average” person with atrial fibrillation is five times more likely to suffer a stroke than someone without, but still most likely not to have a stroke in a given year. Meanwhile, treatments like blood thinners mean a person could die more quickly in a serious accident or a variety of medical scenarios that cause internal bleeding.

These are risks Apple and the FDA are willing to let consumers take.

Before you snap up the $399 Apple Watch Series 4, don’t forget an even more valuable heart health device you can put on your wrist for under $50: a blood pressure monitor. High blood pressure is 10 to 15 times more common than atrial fibrillation and easily treatable.

But the ECG app integration isn’t the only new feature. The new Apple Watch will deploy its internal movement and position sensors to detect a sudden hard fall, the kind where you lurch forward and fling your arms out. If after such a tumble the watch detects no movement, it will assume you’re out cold and need help. This is even better than the old “I’ve fallen, and I can’t get up” life alert systems, which require that you’re awake and alert enough to push a button. Your super-smart Apple Watch will call while you’re unconscious.

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    One caveat: The Apple Watch is still a power hog. With light use, it only lasts 18 hours – and far less if you’re tapping away at its cool features all day. You’ll need to plug it in nightly, so in the middle of the night, when most people could use a fall monitor, you won’t be wearing it. Instead, the watch will be charging on your nightstand when you’re crawling out of bed on your way to the bathroom.

    The Apple Watch’s health features will probably cause a few headaches, but I think the saved lives will be worth it on the whole. If you’ve got money left over after buying your blood pressure monitor, it may just be worth the investment.