An emergency physician took to Reddit to explain the Apple Watch ECG and what the FDA approval actually means.

In summary, the new Apple Watch looks like a great tool, but it is not meant to be a medical grade device and not a substitute for medical and professional evaluation in the case of symptoms. Even if your Apple Watch ECG appears totally normal that does not necessarily mean you do not have atrial fibrillation or other cardiac abnormalities.

Basically, I was totally wrong when I wrote about the ECG function. Also, FDA-approved doesn’t mean the Apple Watch is a medical device. It’s in the Class II category which puts it on the same level as condoms and home pregnancy kits. The Verge has details as well.

Check It Out: An Emergency Physician Explains the Apple Watch ECG

4 Comments Add a comment

  1. Roger Wilson

    And that emergency room physician is wrong. If Apple has FDA approval for their Class II device, it’s indeed a medical device, just like 43% of all medical devices which are also in that classification, subject to a 510(k) submission, quality and design controls, extensive testing, and Good Manufacturing Practices (GMP) regulations (federal statutes 21 CFR 820). Class II means it’s considered a moderate risk device.

  2. BlackCorvid

    Thanks for the update. Reading the Reddit post brought back old memories of doing EKG’s with straps around the limbs and a suction cup placed at each of the six chest lead positions. It was a laborious and sometimes challenging process that was made obsolete by more recent EKG machines (we still need the Tricorder though). I could see performing most of a 12 lead EKG using the Apple Watch 4 possibly with the help of an assistant, by placing the watch over the appropriate positions on the chest. The AVR, AVL, and AVF leads would be problematic as they require additional limbs to act as ground. Still, for purposes of diagnosing an acute coronary event, it could work in the hands of a knowledgeable individual. Since each lead is stored in the Health App, one could, over the course of about 5 minutes, obtain at least 9 of the 12 leads, and depending on the quality of the tracing, be able to make a pretty good guess about what is going on with one’s heart. This is totally cool technology.

  3. Lee Dronick

    “but it is not meant to be a medical grade device and not a substitute for medical and professional evaluation in the case of symptoms.”

    Apple probably never meant it to be, but if it helps prompt me to see a doctor then it is better than waiting until it is too late.

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