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The ECG app

Discussion of issues related to Apple Watch.
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Ray Bentsen
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The ECG app

Post by Ray Bentsen » Thu Nov 01, 2018 1:01 pm

Here is the info that Apple is providing to its sales people:
What you can say about Apple Watch Series 4, the ECG app, irregular rhythm notifications, and the FDA
• “The ECG app has been granted a De Novo classification by the FDA. What this means is it’s the first-ever ECG app offered directly to consumers. The ECG app will be available to U.S. customers later this year on Apple Watch Series 4.”
• “The irregular rhythm notification has been granted a De Novo classification by the FDA and will be available to U.S. customers later this year on Apple Watch Series 1 and later.”
Remember: It’s the ECG app, the irregular rhythm notifications, and associated software that are government-regulated, not Apple Watch Series 4. It’s not correct to say that Apple Watch or even the ECG app and associated software are “approved” by the FDA.

How the ECG app on Apple Watch Series 4 works
• “Apple Watch Series 4 and the ECG app work together to analyze your heart rhythm in order to provide a classification of sinus rhythm or atrial fibrillation.”
Remember: The ECG app and Apple Watch Series 4 enable this feature, not just Apple Watch Series 4. • “The ECG app on Apple Watch Series 4 generates an electrocardiogram, similar to a single-lead ECG.”
Remember: The electrocardiogram generated by the ECG app is similar to a single-lead or Lead I ECG, but it’s not the same.
• “The ECG app can indicate whether your heart rhythm shows signs of sinus rhythm, which means your heart is beating in a normal pattern, or atrial fibrillation—a serious form of irregular heart rhythm. The resulting ECG waveform, its classification, and notes that you enter on related symptoms are automatically stored in the Health app on your iPhone. Your health and fitness information, including information from the ECG app, is always under your control, and it’s encrypted on your devices and in iCloud.”
• “You can share the information with your doctor and have a more informed conversation about your health.”
Remember: The ECG app can indicate whether a customer’s heart rhythm shows signs of atrial fibrillation, but it’s not meant to detect or diagnose AFib or be used for disease management.
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Stephen Hart
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Joined: Thu Apr 07, 2011 11:09 am

Re: The ECG app

Post by Stephen Hart » Fri Nov 02, 2018 10:56 am

In case anyone wants to dive a little deeper into what Apple Watch does, and how it gained FDA approval, and what for, here's an article that clarifies some of the questions:
The study, according to Stanford, sought to determine how many patients who received irregular pulse notifications were found to have atrial fibrillation, and how many went on to get medical attention.
https://appleinsider.com/articles/18/11 ... ries-4-ecg
"Design is not just what it looks like and feels like. Design is how it works."
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