Blood pressure is
where all treatment
decisions begin.

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. (more…)

PyrAmes has been awarded a Catalyzing Pediatric Innovation (CPI) grant by the West Coast Consortium for Technology & Innovation in Pediatrics (CTIP), centered at Children's Hospital Los Angeles. Including PyrAmes, only five innovators were selected for developing novel devices and technologies for pediatric patients in CTIP’s seventh annual competition. PyrAmes was selected for its novel approach to monitor the blood pressure of critically-ill, yet stabilized, infants who have not yet been treated for hypotension, by extending the use of its non-invasive, wearable Boppli® device. There were ~3.6 million live U.S. births in 2020, with 9% to 13% requiring NICU care (~400,000), including monitoring of vital signs such as blood pressure. CTIP is a pediatric medical device accelerator centered at Children's Hospital Los Angeles (CHLA) and the University of Southern California (USC). CTIP promotes the commercialization and clinical use of pediatric medical device technology. Its goal is to support innovators and encourage development of safe, effective medical devices designed specifically for pediatric patients.

CUPERTINO, CA and ARLINGTON, VA — PyrAmes Inc. has received an investment from March of Dimes, the leading organization fighting for the health of moms and babies, to support development and commercialization of its wearable technology to noninvasively monitor blood pressure, particularly for new mothers and their babies. PyrAmes' goal is to develop more convenient, clinically-accurate, blood pressure monitoring for all patients, including both mothers and babies in order to support enhancing their health before and after childbirth. PyrAmes’ Boppli™ device for critically-ill infants received Breakthrough Device Designation from the US Food & Drug Administration (FDA). (more…)