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Withings Hypertension Notification Retrospective Study
Sponsor: Withings
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.
Official title: Validation of the Withings Hypertension Notification Feature (HTNF): A Retrospective Study Comparing Diagnostic Performance Against the FDA-Authorized Predicate Device (Apple Watch HTNF, K250507)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
2500
Start Date
2026-03-01
Completion Date
2026-07
Last Updated
2026-06-08
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Withings SA
Issy-les-Moulineaux, Île-de-France Region, France