Withings Hypertension Notification Retrospective Study

NCT07631715 | Active Not Recruiting FDA Device

• 1 other identifier: HTNF
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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. The study tests whether the Withings HTNF achieves diagnostic performance substantially equivalent to the FDA-authorized predicate device (Apple Watch HTNF, K250507) for the purpose of 510(k) clearance.

Conditions

Hypertension

Keywords

Hypertension; Blood Pressure; Pulse Wave Velocity; Connected Health; Smart Scale; Software as a Medical Device; 510(k); mhealth

Outcome Measures

Primary Outcomes (2)

• Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm

  Percentage of hypertensive user-weeks correctly flagged

  up to 7 years

• Stage-Adjusted Specificity (Sp) of the Withings HTNF Algorithm

  Percentage of non-hypertensive user-weeks correctly not flagged

  up to 7 years

Study Arms (1)

Withings Smart Scale Users

Retrospective cohort of adult consumer users of Withings connected smart scales (Body Cardio, Body Scan, Body Comp) with concurrent Withings blood pressure monitor measurements between 2019 and 2026. The held-out validation subset (\~2,500 users) is drawn from the HealthVerity-linked US cohort to support stage-adjusted Sensitivity and Specificity primary endpoints and subgroup analyses.

Device: Withings Blood Pressure Monitor (reference); Device: Withings Hypertension Notification Feature (HTNF)

Interventions

Withings Blood Pressure Monitor (reference) DEVICE

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 Smart Scale Users

Withings Hypertension Notification Feature (HTNF) DEVICE

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.

Withings Smart Scale Users

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult consumer users (\>= 18 years, \>= 22 years in the US) of Withings connected smart scales (Body Cardio, Body Scan, Body Comp) with concurrent Withings connected blood pressure monitor data, who received the study information letter and did not opt out. The retrospective validation cohort is drawn from a HealthVerity-linked US subset to support subgroup analyses by race, ethnicity, prior hypertension diagnosis, and antihypertensive medication use.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Withings: lead

Study Sites (1)

Withings SA

Issy-les-Moulineaux, Île-de-France Region, 92130, France

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pierre Escourrou, MD, PhD

  Centre Interdisciplinaire du Sommeil, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 8, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)