Clinical Trial: Withings Heart Function Risk Notification Retrospective Study

U.S., June 18 -- ClinicalTrials.gov registry received information related to the study (NCT07654491) titled 'Withings Heart Function Risk Notification Retrospective Study' on June 12.

Brief Summary: This is a fully decentralized retrospective, non-interventional study evaluating the diagnostic performance of the Withings Heart Function Risk Notification (HFRN), a software-only medical device (SaMD) that analyzes longitudinal weight / BMI, body-water-percent variability, and activity (step) data collected passively by Withings connected smart scales and the Withings activity-tracking ecosystem. The study estimates Sensitivity (Se) and Specificity (Sp) of HFRN against a US claims-based (HealthVerity) heart-failure reference standard, evaluat...