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FDA Releases Performance Standards for Cuffless Blood Pressure Monitors
January 24, 2026
WASHINGTON, Jan. 24 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration announced the availability of draft guidance for the clinical testing and evaluation of cuffless non-invasive blood pressure measuring devices. This document provides recommendations for manufacturers to support future premarket submissions for these technologies.

Cuffless devices generally utilize sensors to provide signals from which systolic, diastolic, or mean blood press . . .

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