Development and Internal Validation of an AI-Enabled Cuff-less, Non-invasive Continuous Blood Pressure Monitor Across All Classes of Hypertension.

ABSTRACT:

Background

Non-invasive, continuous blood pressure monitoring technologies require additional validation beyond standard cuff-based methods. This study evaluates a non-invasive, multiparametric wearable cuffless blood pressure (BP) diagnostic monitor across all hypertension classes with diverse subjects.

Methods

A prospective, multicenter study assessed Nanowear's SimpleSense-BP performance, including induced and natural BP changes, significant BP variations (Systolic BP (SBP) ≥ ± 15 mm Hg and Diastolic BP (DBP) ≥ ± 10 mm Hg), and reference input value validity over 4 weeks.

Results

303 subjects (18-83 yrs; 50.16% Female) participated in algorithmic development and validation (Normal - 35%, Prehypertensive - 24%, Stage 1 - 24%, Stage 2 - 17%). 54 subjects were tested

SUBMITTER: Lopez-Jimenez F 

PROVIDER: S-EPMC12043788 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature