Supplementary Material for: Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates

Background: Accurate and continuous blood pressure (BP) monitoring in neonates is crucial in the Intensive Care Unit. Invasive arterial lines, oscillometric cuffs, and current noninvasive continuous BP monitoring devices have significant limitations. The Boppli® device is a novel, continuous, noninvasive BP device that requires no calibration, designed for neonates. Aim & Methods: This prospective, multicenter study evaluated the performance, usability, and safety of the Boppli device in neonates ±5 mmHg. Various subgroups had standard deviations >8 mmHg attributed to low sample sizes. The device received high usability scores from clinicians and parents. No serious adverse events were reported. Conclusions: The Boppli device is a promising alternative for continuous noninvasive BP monitoring in neonates, offering good accuracy and usability. The device, which received 510(k) clearance in September of 2023, was well-received by clinicians and parents, with a low risk profile.