Disclaimer: Due to health regulations and clearances, some ScanWatch Vitals features may not be available or may not have clinical validation in your region. Learn more.

Note: "Scan Monitor" is the name for the ECG functionality in ScanWatch Vitals. 

Study on ECG Accuracy and Atrial Fibrillation Detection Algorithm

A clinical study (ClinicalTrials.gov Identifier: ongoing) was conducted to validate that Scan Monitor software could perform a medical-grade electrocardiogram and detect atrial fibrillation with these tracings. Scan Monitor ECG recordings were compared to 12-lead ECG recordings and reviewed in a blind assessment by 3 cardiologists. The study was approved by an ethics committee. It was carried out according to Good Clinical Practice, the ISO 14155 standard, and the Declaration of Helsinki. Each participating patient gave written consent.

The study took place in several centers, including Centre de Cardiologie du Nord (CCN) & Hôpital Européen George Pompidou (HEGP), using a sample of varied age, height, weight and sex. Approximately half of participants had atrial fibrillation. Physicians simultaneously recorded an electrocardiogram with Scan Monitor and a 12-lead baseline electrocardiogram on each patient before comparing the tracings. They used the reference ECG to make a diagnosis. They also conducted a blind review of the ECGs from the reference ECG or the watch to analyze the quality of the waveforms and waveforms (P wave, QRS wave, T wave, and duration of PR/QT/QRS intervals). 

The results showed that: 

1. Scan Monitor measures a trace that is extremely consistent with the reference on all the characteristic waves of an ECG. 
2. The atrial fibrillation (Afib) detection algorithm demonstrated a sensitivity and specificity of 1 (lower bound of the confidence interval at .92 and .94 respectively) on record for the classification of ECGs as AF or normal sinus rhythm. One-fifth of the records were classified as inconclusive by the algorithm because they showed poor signal quality or arrhythmias of other types than Afib.