Apple Watch Series 4 can detect Afib and perform an ECG

Announced by Apple today:

Apple Watch Series 4 can detect Afib and perform an ECG

FDA approved for ECG.

"Won't catch all afib, but can alert some people who didn't know they had a problem."

Starts at $399, available Sept. 21.


**this is not an endorsement**

Saw that but why is appl shares taking a dip, the watch sounds pretty good.

Liz

Will be interesting to see if Apple’s sensor provides higher fidelity than Kardia. Both are obviously just single lead and have the limitations inherent thereof.

While I’m a fanboy, I’m also skeptical. The current heart rate sensor is usually accurate, but when it’s wrong, it’s really wrong. It’s not unusual for it to double or half my actual rate. If the afib algorithm is aggressive and the sensor is noisy then ER’s and EP’s will be overwhelmed more than they already are. And remember, you have to go all in to the ecosystem as the watch itself won’t work without an iPhone. Also, I don’t believe the FDA approval means what it once did. They are on record saying that they are fast-tracking devices.

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AB Page
Will be interesting to see if Apple’s sensor provides higher fidelity than Kardia. Both are obviously just single lead and have the limitations inherent thereof.

While I’m a fanboy, I’m also skeptical. The current heart rate sensor is usually accurate, but when it’s wrong, it’s really wrong. It’s not unusual for it to double or half my actual rate. If the afib algorithm is aggressive and the sensor is noisy then ER’s and EP’s will be overwhelmed more than they already are. And remember, you have to go all in to the ecosystem as the watch itself won’t work without an iPhone.

On one iPhone app which uses the camera & light as a plesmograph, the doubling is fairly common. I have to admit, I'm using this when I'm doing breathing exercises which increase serum CO2. This can significantly change the pulse waveform. This can change the amplitude of the dicrotic notch compared to that of the pulsewave peak. Interestingly, it doesn't fool my fingertip pulse/ox. Don't wear a wrist device and don't want to. If I really want to look at my ECG, I'll use a Kardia.

When I had un treated afib, my pulse went form 55 to 180. No watch needed to detect afib.

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Ken
When I had un treated afib, my pulse went form 55 to 180. No watch needed to detect afib.

Kind of the way I feel about any device that can detect afib. I know when I’m in it!

Here's a link to a letter Apple received from the FDA regarding

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The Irregular Rhythm Notification Feature

on/in the Apple Watch Series 4.

[www.accessdata.fda.gov]

It's important to note that the study Apple did used earlier models of the Apple Watch OS that measures changes at the skin surface, known as photoplethysmography. It's what's used in a pulse oximeter and other non-invavsive devices.

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The Irregular Rhythm Notification Feature is a software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user. The feature is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment.
The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.

What to me is not quite clear is how the sensors in the Series 4 have changed, compared to earlier models.

The cardio twitter community is not happy with Apple for the most part, nor with the American Heart Association president Dr. Ivor J. Benjamin who blessed the device and software on stage at the Steve Jobs Theater Wednesday. To be clear, Apple never claimed to have the first consumer device capable of taking a 1 lead ECG. What Tim Cook said was they have the first FDA approved standalone device. (Though I question this as an Apple Watch is non-functional if it isn't paired to a modern iPhone.) The nuance here is the Kardia requires 2 things - it's device and a smartphone. Kardia, while apparently blindsided and feigning exasperation, welcomed being drawn into the limelight that this trillion dollar company generated for them, going so far as to admit product orders saw a significant increase after the Apple unveiling.

So the FDA blessing (technically a level called "clearance") of the Series 4 Watch also includes a separate letter for the ECG over the counter software.

[www.accessdata.fda.gov]

The Verge does a great job of explaining it here.

I didn't realize there are different levels of classification including clearance and approval. Also interesting, but not surprising, is that Apple is using semantics to its advantage in claims of being "first". Apple is rarely first at anything, but frequently they are best. Best is of course subjective

The ECG and Irregular Rhythm Notification Feature won't be enabled until later this year via a software update.