It’s a watch, it’s a phone, it’s a medical device?
At the annual September convention, Apple launched the Apple Watch Series 4 that comes packed with health features. It will warn when a wearer has fallen down, it will monitor your heart rhythm and it will enable customers to take an ECG or electrocardiography reading, right from their wrist.
With the app, users touch the Digital Crown and after 30 seconds, receive a heart rhythm classification. It can classify if the heart is beating in a normal pattern or whether there are signs of Atrial Fibrillation (AFib), a heart condition that could lead to major health complications.
At the launch, Apple claimed the app came with Food and Drug Administration’s ‘approval’. Since then, they’ve clarified that they have FDA’s ‘clearance’. FDA is US federal public health regulator.
But coming back to the original question, is it a legit medical device?
What Can the Apple Apps Do?
The Apple ECG app can perform what is called a single-lead electrocardiogram. To clarify, a regular medical ECG machine is a 12-lead electrocardiogram.
A 1-lead ECG records the electrical activity of only the lateral wall of the left ventricle of the heart.
This means the app can only tell if the wearer suffers from Atrial Fibrillation or AFib, an irregular and often rapid heart rate that can increase your risk of stroke, heart failure and other heart-related complications, says Mayo Clinic.
A medical ECG, that you get done in a hospital, involves using 10 electrodes to record 12 different views of your heart’s electrical activity. Electrodes are attached to each ankle and wrist and the chest. According to this resource, and ECG can tell a doctor if you have (among other things):
- Irregular heartbeat
- Issues with spread of electrical activity within the heart
- An enlarged heart
- Areas where there is reduced blood supply
- A silent heart attack
Only a medical doctor can read the medical ECG and make a diagnosis.
To one up Apple’s claims, AliveCor, a company that has made Apple’s health accessories in the past, has said they are coming out with its own ECG reader, that will have 6 leads, as opposed to 1 that Apple has. And they also have the FDA clearance.
FDA ‘Clearance’ vs ‘Approval’
The letter from the FDA that has cleared the device clearly states that it is for ‘over-the-counter’ use and the data is intended for ‘informational’ use only.
The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG wave form is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.
The letter further says it is not intended for use among those under 22 years of age.
The FDA clearance letter for Apple’s Heart Rhythm app is also on similar lines - data for information only, not for under 22-year-olds, and please visit a doctor if you get a warning from your watch.
BUT... Still Pretty Cool, Right?
Medical-related artificial intelligence is the way forward. The large amount of data collected can help doctors better determine outcomes, predict possible health issues and address them before they do more damage.
The global smart wearable devices market was valued at USD 16.2 Million in 2016 and is anticipated to reach at a valuation of USD 52.5 Billion by the end of 2024, according to this report.
From ECG, to heart rate monitors, BP and blood sugar monitors to even oximeters that determines a person’s oxygen saturation, heart rate and respiratory rate - the wearables are already changing the way we look after ourselves. Experts predict these devices will help reduce the cost of healthcare.
What wearable devices won’t be able to do, is to actually study this data, diagnose and cure. For that, you’ll still need doctors.
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