Disclaimer: Due to health regulations and clearances, some ScanWatch 2 features may not be available or may not have clinical validation in your region. Learn more.
Clinical Validation of the ScanWatch 2 ECG feature
The ScanWatch 2 ECG feature, which is integrated into the ScanWatch 2, underwent a clinical study to confirm its ability to generate a medical-grade electrocardiogram (ECG) and accurately identify atrial fibrillation (AF) and sinus rhythm (SR) from that signal. This investigation, known as the Withings ECG App Study, was a prospective, cross-sectional, diagnostic, multi-center, open-label study featuring a blinded independent central review. It strictly followed Good Clinical Practices (GCP), ISO 14155, the Declaration of Helsinki, and relevant US (21 CFR parts 11, 50, 56) and international regulations. Ethical oversight was provided by independent ethics committees and institutional review boards, and all participants provided written informed consent.
The study enrolled 694 patients across 10 clinical sites in the United States and France, with 626 included in the primary analysis. The patient population was diverse in terms of age, gender, and medical history, with approximately half of the participants presenting with atrial fibrillation. The validation methodology involved simultaneously recording ECGs using both the Withings ScanWatch 2 (the Device Under Test, DUT) and a 12-lead reference ECG (Schiller CARDIOVIT FT-1), which served as the gold standard for comparison. These recordings were then evaluated by an independent board of certified cardiologists who were blinded to the origin of the ECG strips and patient history, ensuring impartial assessment.
In conclusion,the clinical validation study of the ScanWatch 2 ECG feature provides strong evidence that the ScanWatch 2 offers reliable and safe detection of atrial fibrillation and accurately measures heart rate. The quality of the ECG recordings produced by the device is equivalent to that used in standard clinical practice. The overall assessment indicates that the health benefits associated with improved AF detection outweigh any potential risks of inaccurate or imprecise results, underscoring its potential to enhance early detection and management of this significant heart condition.
Clinical validation of the ScanWatch 2 PPG feature
The ScanWatch 2 PPG feature was assessed through a clinical study to confirm its ability to identify atrial fibrillation based on a photoplethysmography (PPG) signal. This investigation was a diagnostic, prospective, multicentric study, conducted in accordance with the Good Clinical Practices (GCP), ISO 14155, ICH guidelines and the declaration of Helsinki. Ethical oversight was provided by an independent ethics committee, and all participants provided written informed consent.
The study enrolled 168 patients across 2 clinical sites in France, with 166 included in the analysis. The patient population was diverse in terms of age, gender, and medical history, with approximately half of the participants presenting with atrial fibrillation.
The validation methodology involved simultaneously recording the PPG signal from the device under test (DUT) and a 12-lead reference ECG (Schiller CARDIOVIT FT-1), which served as the gold standard for comparison. The ECG recordings were evaluated by an independent board of certified cardiologists who were blinded to the origin of the reference ECG strips and patient history, ensuring impartial assessment.
In conclusion, this clinical validation provides strong evidence that the ScanWatch 2 offers reliable and safe detection of atrial fibrillation through PPG. The overall assessment indicates that the health benefits associated with improved AF detection outweigh any potential risks of inaccurate or imprecise results, underscoring its potential to enhance early detection and management of this significant heart condition.