A Prospective, Cross-Sectional, Multicenter Pilot Study to Assess the Efficacy of NerveVue: A Non-Invasive, Multi-Site Diagnostic Tool for Peripheral Artery Disease

Peripheral Artery Disease (PAD) remains significantly underdiagnosed even among high-risk populations particularly in primary care and underserved settings due to the dependency on Doppler-based Ankle-Brachial Index (ABI) measurements, which is time-consuming, need a trained personnel and specialized equipment. NerveVue is a novel, portable diagnostic system that integrates photoplethysmography (PPG) and piezoelectric sensors to capture arterial pressure wave form signals from all four limbs simultaneously. Designed for use by low-skill operators, NerveVue enables rapid, infrastructure-light PAD screening suitable for decentralized and outreach environments. MethodsA prospective, cross-sectional, multicenter clinical study was conducted involving 299 adults across standard middleage to older-age ranges. Ankle-Brachial Index (ABI) values derived from the NerveVue device (ABI_NV) were compared against the reference Handheld Doppler method (ABI_Ref). Diagnostic performance metrics including sensitivity, specificity, and predictive values were computed. Subgroup analyses were performed for participants with diabetes, hypertension, and smoking history. Agreement between ABI_NV and ABI_Ref was assessed using Pearson correlation coefficients and PAD classification concordance. ResultsNerveVue demonstrated an overall accuracy of 91.6%, with a sensitivity of 84.6% and specificity of 94.7% compared to Handheld Doppler-based ABI measurements. The correlation between ABI_NV and ABI_Ref was strong, with Pearsons r = 0.991 (right limb) and r = 0.992 (left limb), both statistically significant (p < 0.00001). Subgroup analysis showed consistent performance, with enhanced sensitivity among diabetic participants (90%) and perfect sensitivity among smokers (100%). The system enabled rapid PAD assessment within five minutes using low-skill operators, making it suitable for decentralized screening environments. ConclusionNerveVue provides a reliable and accurate alternative to Dopplerbased ABI for the detection of Peripheral Artery Disease (PAD), demonstrating high diagnostic agreement and robust performance across diverse risk groups. Its simultaneous multi-site measurement and ease of use by low-skill operators, position it well for large-scale deployment in community screenings, primary care, diabetic clinics, and preventive health programs. NerveVue has the potential to bridge current diagnostic gaps and enable earlier intervention in vascular disease management.