Apple Watch ECG feature may come to Malaysia soon, according to a Medical Device Authority filing

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Source: Xavier Naxa on Twitter.

Apple’s acclaimed ECG feature on the Apple Watch Series 4 and later (except Apple Watch SE) may be coming to Malaysia soon, according to a new regulatory filing.

The regulatory filing posted by Malaysia’s Medical Device Authority states “Apple Watch ECG” as the name of the newly registered device. It’s an indication that the ECG app might be coming to Malaysia, probably with the release of iOS 14.5 and watchOS 7.4.

The ECG app on the Apple Watch is used to detect atrial fibrillation (AFib) and irregular heart rhythm. Apple says that it’s not a definitive indication of the condition and you still need to consult a doctor upon detection.

The regulatory filing also mentions the intended usage of ECG:

  • The ECG 2.0 app is not recommended for users with other known arrhythmias.
  • The ECG app is intended for over-the-counter (OTC) use.
  • The ECG data displayed by the ECG app is intended for informational use only.
  • The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
  • The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.

Currently, not all countries support the Apple Watch’s ECG functionality even though the devices support it. This is mainly due to regulatory hurdles that Apple has to face in different countries. ECG on the Apple Watch is currently available in 63 countries.

The ECG app is proven to be a lifesaver, as documented in a number of cases. Apple also recently shared a case study highlighting the ECG feature.

Apple updated ECG to version 2 alongside iOS 14.3 and watchOS 7.2. The latest version brings even more accuracy, a heart rate checking limit up to 150 bpm as opposed to 120 bpm in the previous version, and more flexibility in how you use ECG on your Apple Watch.


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