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Apple Watch Detects AFib and Falls?!

The newest Apple iWatch has actually obtained FDA approval to be sold “over-the-counter” as a medical device. We know the older watches have had the ability to monitor heart rate, but now it has an algorithm to allow it to recognize an abnormal heart rate called atrial fibrillation, and to take a 1-lead ECG.

If this watch is continuously monitoring your heart rate, it can warn the patient and hopefully they seek medical advice. BUT:

What was the FDA approval process for this watch?

What is the sensitivity and specificity of the watch for the detecting a-fib?

Are people going to put too much reliance into this watch? Think false positive hysteria and false negative missed runs of AFib.

Image result for atrial fibrillation animation

What is atrial fibrillation?

Atrial fibrillation is an irregular heartbeat that can lead to blood clots, stroke, heart failure and other complications. Some people may have no symptoms, but if the heart rate increases to a dangerous level, it can cause dizziness, chest pain, and nausea.

At least 2.7 million Americans are living with Afib. INCLUDING ZDADD!

Why is atrial fibrillation dangerous?

When the atrium doesn’t contract correctly, clots can form and dislodge into the bloodstream. When that clot lodges in an artery feeding the brain, a stroke results. About 15–20 percent of people who have strokes actually have afib. Blood thinners can lower this clot risk.

Patients also may be put on medications to regulate heart rate if rapid rates are a problem.

Mechanical Falls

The new Apple watch apparently has an algorithm to detect the movement patterns associated with falls and alert the authorities if you don’t respond after the fall. It will be interesting to see how well it works!

The Apple Watch FDA Approval Letter

Here are the key excerpts:

The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.”

“The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app 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 waveform 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.”

If you want to read the rest, you can check it out here.

ZPac, check out the original video here on Facebook and let me know what you think about this watch! Would you use it? Do you think it’ll be a helpful adjunct to the healthcare team? (No podcast version of this episode because my audio got screwed up at a couple points, sorry peeps!).