Apple Watch 4 – The First Over-the-Counter ECG Product

Apple Watch 4 – The First Over-the-Counter ECG Product

On September 12th 2018, Apple COO Jeff Williams proudly unveiled the Apple Watch 4, which contains the first over-the-counter ECG reading capability. According to Fast Company, Apple barely made the cut with the FDA’s clearance for this new ECG technology. Apparently, Apple had only received FDA de novo clearance from the FDA one day prior to their big announcement.

The new and improved Apple Watch 4 has capabilities of generating an ECG similar to a single-lead electrocardiogram. Apple has stated that it hopes to provide critical real-time data for doctors and a peaceful mind for the users. The ECG application is expected to come later this year.

How It Works

There are electrodes built into the Digital Crown and Back Crystal which work together with the ECG app to read the user’s heart’s electrical signals. The Digital Crown contains a titanium electrode which reads the electrical heart impulses in one’s fingertip, while the Back Crystal Electrode contains an ultrathin chromium silicon carbon nitride layer applied to the sapphire crystal. This crystal reads the electrical heart impulses in the wrist of the user.

Within thirty seconds of touching the Digital Crown, an ECG waveform will appear. This technology will determine whether or not the user’s heart is showing signs of an atrial fibrillation or sinus rhythm. The results from one’s ECG waveform, its classification, and any notes entered on related symptoms can be automatically stored in the Health app in the iPhone. These results and notes can later be shared with the user’s doctors, leaving room for further discussion about their health.

AliveCor One-Ups the Apple Watch

While Apple’s announcement of their Apple Watch 4’s ECG single-lead capabilities were unheard of at the time, it was only a week later that AliveCor revealed that they will be coming out with a “never-before-seen” six-lead electrocardiogram.

This ECG is still pending FDA approval, but is quite a big step up from the Apple Watch 4’s single-lead applicability. While the Apple Watch’s main focus is picking up on any AFib, AliveCor’s six-lead watch will theoretically allow its user to detect around one-hundred different diseases.

One of the most notable detections this watch could pick up would be ST elevation, which is one of the main elements linked with the inception of a heart attack. This could help get a patient to the hospital even before they begin exhibiting other physical symptoms.

While it is possible that Apple could upgrade their Watch to a six-lead ECG reader, CEO AliveCor stated they have some pretty good patents in the space. However, this is all speculative still, as AliveCor still has yet to name their six-lead ECG watch and doesn’t plan to bring it to the market until 2019.


With this race for more improved and reliable technology, users can potentially be better aware of their health. The need for a cardiologist is still necessary, however, to read these ECG tracings and interpret them to the patient. We look forward to see how this all unfolds for the overall benefit of patient wellbeing and awareness.


“Apple Watch Series 4 - Health.” Apple (Canada), 2018,

Sullivan, Mark. “Whew! Apple Watch ECG Was a Heartbeat Away from Missing FDA Nod.” Fast Company, Fast Company, 18 Sept. 2018,

Buhr, Sarah. “Not to Be Overshadowed by the Apple Watch, AliveCor Announces a New 6-Lead ECG Reader.” TechCrunch, TechCrunch, 17 Sept. 2018,

Mar 6th 2019 Jaken Medical

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