Withings Blood Pressure Monitor (reference): Ground-truth weekly average systolic and diastolic blood pressure measurements obtained from Withings connected blood pressure monitors (BPM \[WPM02\], BPM+ \[WPM03\], BPM Core \[WPM04\], BPM Connect \[WPM05\]), validated as non-invasive oscillometric blood pressure monitors per ISO 81060-2:2018. Minimum 7 measurements per user-week required.
Withings Hypertension Notification Feature (HTNF): The Withings Hypertension Notification Feature (HTNF) is a software-only medical device (Software as a Medical Device, SaMD) that analyzes demographic, anthropometric, and physiological parameter data opportunistically collected by Withings connected smart scales to identify patterns suggestive of hypertension and provide a notification to the user.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
Accepted
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)
Primary outcome measure(s)
Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm — up to 7 years Percentage of hypertensive user-weeks correctly flagged
Stage-Adjusted Specificity (Sp) of the Withings HTNF Algorithm — up to 7 years Percentage of non-hypertensive user-weeks correctly not flagged
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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