Evaluation: Apple Watch Series 4 Medical Smartwatch

November 4, 2020 | Evaluations & Guidance

Preview

  • The primary medical purpose of the Apple Watch Series 4 is to record, analyze, store, and send single-lead ECG tracings.
  • In addition, the watch has two supplementary medical features:
    • Passive detection of atrial fibrillation (AFib) via analysis of heart rate and rhythm as recorded by the photoplethysmography (PPG) sensor. We did not evaluate this feature.
    • Fall detection and emergency alerts
  • Major components and software features: a) Watch
    • ECG electrodes
      • The watch has two ECG electrodes, one on the underside where the watch rests on the wrist and one on the "digital crown" button/knob on the side of the watch.
      • To record a single-lead ECG, the user opens the ECG app on the watch, then places a finger from the hand not wearing the watch on the digital crown, completing lead I.
    • PPG sensor (a) The PPG sensor is on the underside of the watch and constantly measures the wearer's heart rate.

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