Evaluation: Fitbit Sense Medical Smartwatch

June 30, 2022 | Evaluations & Guidance

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  • The primary medical purpose of the Fitbit Sense is to record, analyze, store, and send single-lead ECG tracings.
  • In addition, the watch performs 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.
  • The watch has several nonmedical (i.e., not cleared by FDA) wellness features that we did not assess, including pulse oximetry and sleep analysis. It also has numerous quality-of-life and convenience features.
  • Major components...

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