Functionality of the electrocardiogram in the new models Apple Watch Series 4 limited to the United States, coming later this year

The Apple Watch Series 4 models include a heart rate sensor designed to receive an electrocardiogram (ECG) using an ECG application, the built-in sensor and the electrodes included in the digital crown. Later this year.

According to Apple's Apple Watch Series 4 website, the ECG application that will allow the use of the electrocardiogram function will be available in the course of 2018. At startup, the ECG functionality will no longer be functional.

Like many MacRumors Readers pointed out that ECG readings would be limited to Apple Watch models sold in the United States. The pages of the Apple Watch 4 series for countries like the United Kingdom and Canada contain no mention of the feature, and Apple's press release for Series 4 models indicates that the ECG feature is only available in the United States. -United.

To perform an ECG reading from the Apple Watch, users will need to place a finger on the digital crown while wearing the watch. Reading is completed in just 30 seconds, allowing users to determine if their heart beats regularly or if there are signs of atrial fibrillation, which can be an indicator of serious health problems.

Atrial fibrillation is an often undiagnosed health problem. The ECG function of the Apple Watch will therefore be very useful for detecting the early signs of the disease. The ECG readings also normally require a full ECG device and a visit to the doctor, which is much less convenient than a reading done with the Apple Watch.

Apple claims that the FDA has awarded the ECG feature of the Apple Watch a rating as described on the FDA website [PDF], and the need for regulatory approval is probably the reason why the ECG function is not available in other countries.

The approval of De Novo FDA is a preliminary approval process granted to new devices that are not likely to cause damage. According to the FDA, the ECG feature of the Apple Watch should only be used for information purposes, should only be used by people over the age of 22 and is not recommended for people with known arrhythmia.

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

The ECG application is intended for over-the-counter use. The ECG data displayed by the ECG application is intended for informational use only. The user does not intend to interpret or take any clinical measures based on the results of the device without consulting a qualified health professional. The ECG waveform is intended to complement the rhythm classification in order to distinguish AFib from normal sinus rhythm and not to replace traditional methods of diagnosis or treatment.

The ECG application is not intended for people under 22 years of age.

Apple has also obtained FDA approval for the functionality of the Apple Watch Series 4 models that sends notifications when an irregular heartbeat is detected via the ECG function or via standard Apple Watch heart rate monitoring.

All ECG data collected by Apple Watch Series 4 models are stored in the Health app in PDF format and can be easily shared with physicians.