Withings Hypertension Notification Retrospective Study

This retrospective, non-interventional clinical investigation evaluates the diagnostic performance of the Withings Hypertension Notification Feature (HTNF), a software-only medical device (SaMD) that analyzes demographic, anthropometric, and physiological parameters collected by Withings connected smart scales to identify patterns suggestive of hypertension. Ground-truth blood pressure measurements are obtained concurrently from Withings connected blood pressure monitors.

Inclusion Criteria: * Users of commercially purchased, consumer-grade Withings smart scales (models Body Cardio, Body Comp, Body Scan) in a standard home environment * Concurrent ground-truth blood pressure data collected via Withings connected blood pressure monitors (BPM, BPM+, BPM Connect, or BPM Core) * At least 7 blood pressure measurements within a given week to establish reliable weekly hypertension status classification * Age \>= 18 years (all regions) or \>= 22 years (United States), consistent with the predicate device age requirement * Receipt of the study information letter without exercising the right to opt out (for applicable regulatory jurisdictions) Exclusion Criteria: * Users lacking valid weekly average systolic and diastolic blood pressure measurements (missing ground truth) * Users with physiological measurements falling outside plausible clinical ranges (BMI \< 10 or \> 100 kg/m2, age \< 18/22 or \> 100 years) * Users who exercised their right to opt out of the retrospective study * Users without an individual Withings account (shared accounts are excluded to prevent data contamination)