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Withings HFRN Retrospective Study
Sponsor: Withings
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)
Official title: Validation of the Withings Heart Function Risk Notification (HFRN)
Key Details
Gender
All
Age Range
45 Years - 120 Years
Study Type
OBSERVATIONAL
Enrollment
9000
Start Date
2026-06
Completion Date
2026-09
Last Updated
2026-07-01
Healthy Volunteers
Yes
Conditions
Interventions
Withings Heart Function Risk Notification (HFRN)
Software-only medical device (SaMD)
Claims-based heart-failure adjudication (reference standard)
Ground-truth heart-failure case / control status derived from administrative claims by a deterministic, pre-specified rule set.
Locations (1)
Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites
Issy-les-Moulineaux, Île-de-France Region, France