Boppli provides essential clinical information for newborns undergoing critical care
Cupertino, CA, September 29, 2023 — PyrAmes Inc., a digital health company pioneering innovative blood pressure (BP) monitoring solutions, today announced it has received FDA 510(k) clearance for its revolutionary Boppli®
platform to continuously and non-invasively monitor the blood pressure of critically-ill infants. Boppli offers safe and accurate BP monitoring as an alternative to invasive arterial lines (IAL) and intermittent cuff-based measurements.
Boppli previously received Breakthrough Device Designation from the FDA, recognizing its potential to enable more timely identification of life-threatening conditions. It is the only commercially-available, continuous and non-invasive BP monitoring solution for infants.
Boppli improves ease of use and avoids the risks and costs associated with IALs. Boppli also eliminates the cumbersome and time-consuming nature of standard cuff-based measurements, which provide only occasional spot BP values and may be prone to inaccuracies. Boppli accuracy was demonstrated to be within FDA guidelines during a rigorous, pivotal clinical study by comparing Boppli sensor data against simultaneous IAL data for critically ill infants in multiple neonatal intensive care units (NICU) in the U.S. and Canada.