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.

Note: "Withings ECG App" is the name for the ECG feature in ScanWatch 2. 

Clinical Validation of Withings ECG App

Withings ECG App, 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 Withings ECG App provides strong evidence that Withings ECG App 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 false results, underscoring its potential to enhance early detection and management of this significant heart condition.