News & Updates

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…)

PyrAmes’ innovative Boppli™ blood pressure device is featured in the journal Sensors, in a paper reporting a clincal study of 81 infants undergoing critical care at Lucile Packard Children’s Hospital Stanford. Sensors is a leading international, peer-reviewed journal on the science and technology of sensors. The paper, Clinical Study of Continuous Non-Invasive Blood Pressure Monitoring in Neonates, highlights the performance of PyrAmes’ novel algorithm-based blood pressure sensor. Boppli is designed to meet the blood pressure monitoring requirements and physical dimensions of small, prematurely-born infants, without external calibration. Boppli uses machine-learning techniques to extract blood pressure values from the shape of the pulse waveform, and is currently being considered for market clearance by the FDA as a Class II medical device. The paper indicates the use of Boppli is feasible for critically ill term and preterm infants with a wide variety of pathologies—from serious cardiac ailments, pre- and post-operative cases, neurologic conditions, and prematurity.

PyrAmes is among only 10 companies chosen to enter the final Technology Assessment phase of the National Institutes of Health (NIH) RADx Tech for Maternal Health Challenge. The goal of the RADx Challenge is to improve maternal health outcomes for those who live in areas lacking access to maternity care through innovative promising home-based or point-of-care diagnostic devices, wearables, and other remote sensing technologies. PyrAmes’ submission, Non-invasive, Continuous Blood Pressure Monitoring for Postpartum Maternal Health, focuses on its Bosimi™ platform, a noninvasive, wearable sensor designed to monitor blood pressure of women in their postpartum period, when the risk of maternal mortality is highest. (more…)

PyrAmes has been awarded first place in the Early Commercialization Innovation Track in Bear Institute's second annual Pediatric Accelerator Challenge for Kids (PACK). The Bear Institute for Health Innovation is a partnership between Children's National Hospital and Oracle Health Cerner Corporation using HIT to improve the quality of care for children. The PACK awards recognize pediatric digital health innovations of start-up and early-stage companies working to bring innovative technologies to market for children.

SW National Pediatric Device Innovation Consortium recognizes Boppli™ platform for pediatric medical device innovation CUPERTINO, CA and HOUSTON, TX, October 21, 2022 – The Southwest National Pediatric Device Innovation Consortium (SWPDC) awarded PyrAmes $25,000 for its Boppli platform— a non-invasive wearable sensor intended for neonatal ICU patients for continuous blood pressure monitoring with minimal skin contact, which serves as a potential alternative to arterial catheters and inflatable cuffs. The American Academy of Pediatrics (AAP) Section on Advances in Therapeutics and Technology (SOATT) annually recognizes pediatric device innovation. A great need currently exists for medical devices designed specifically for children, which is most likely a result of economic, clinical, and regulatory challenges, as well as a lack of established mechanisms for joining pediatric device ideas with qualified individuals/programs and industry partners to create innovative and needed pediatric devices. (more…)

PyrAmes’ novel Boppli™ device enables continuous, noninvasive blood pressure monitoring (cNIBP) for the hospital’s most fragile patients. PROVIDENCE, RI and CUPERTINO, CA, September 13, 2022 — Sentec and PyrAmes have established a commercial partnership to bring Boppli, PyrAmes’ first-of-its-kind continuous noninvasive blood pressure device, to neonatal intensive care teams throughout the United States. Boppli has received Breakthrough Device Designation from the US Food & Drug Administration (FDA) and will be available after FDA 510(k) clearance, which is anticipated in the first half of 2023. “We are excited to join forces with Sentec to commercialize our Boppli product,” said Xina Quan, PhD, Co-Founder and CEO of PyrAmes. “This important step enables us to bring our breakthrough technology to market and transform patient care. We believe Sentec is an ideal partner for us in the NICU, given our companies’ shared mission and focus on noninvasive technologies to enable better healthcare delivery.”In the neonatal intensive care unit (NICU) today, a baby’s blood pressure is either monitored continuously through an invasive arterial catheter or intermittently through cuff measurements. Both techniques present certain clinical challenges. The Boppli™ platform offers a new solution to overcome those challenges. (more…)

PyrAmes chosen from 1,300+ applicants to collaborate with LG on innovative connected health products. CUPERTINO, CA, February 10, 2022 -- PyrAmes, Inc., a digital healthcare company focused on innovative products for continuous blood pressure monitoring, today announced its selection by the LG Electronics North American Innovation Center, LG NOVA in its inaugural cohort of startups selected in its large-scale Mission for the Future global challenge competition. Chosen from a group of over 1,300 applicants, the “First 50” companies represent new developments in several areas including Connected Health, and will work with the LG NOVA team on their business concepts. (more…)

The PyrAmes Boppli™ device is featured on page 11 in the Winter 2022 edition of Neonatal Intensive Care: The Journal of Perinatology-Neonatology. The article focuses on how the Boppli is being developed to meet the need for continuous, non-invasive blood pressure monitoring in the neonatal intensive care unit (NICU).

Plug and Play Japan and its 49 corporate partners have selected PyrAmes for its global accelerator program, including 67 companies from Japan, the U.S., Canada, India, the United Kingdom, Spain, and more. PyrAmes receives business development resources in the program’s Health track, focusing on Plug and Play’s interest in sensors and wearables. Plug and Play Japan is a subsidiary of Plug and Play; a global innovation platform headquartered in Silicon Valley. Its major strength is to provide consortium-type programs with its extensive global network.

PyrAmes’ breakthrough blood pressure sensor is featured in Sensors, the leading international, peer-reviewed journal on the science and technology of sensors. The paper, Advances in Non-Invasive Blood Pressure Monitoring, highlights the added value of PyrAmes’ novel algorithm-based blood pressure sensor which uses machine-learning techniques to extract blood pressure values from the shape of the pulse waveform. The paper reports results from preliminary studies on a range of patient populations and discusses the accuracy and limitations of this capacitive-based technology and its potential application in hospitals and communities.

Cupertino, CA, -- (Marketwired - April 20, 2021) – PyrAmes, Inc., a digital healthcare company focused on innovative products for continuous blood pressure monitoring, today announced the completion of a $6 million Series A financing. The investment round was led by GSR Ventures, with co-investments from Keytone Ventures, XTX Ventures and other investors. (more…)

PyrAmes Inc. is proud to announce that the FDA has granted Breakthrough Device Designation (BDD) to Boppli™, which fills the unmet need of monitoring the blood pressure of critically ill infants when an invasive arterial catheter cannot be used due to the risk of complications and adverse effects. (more…)

PyrAmes is honored to be selected by the Southwest National Pediatric Device Innovation Consortium (SWPDC) as a winner of the SWPDC Spring Competition. The SouthWest National Pediatric Device Innovation Consortium (SWPDC) is a “free no-strings-attached” virtual accelerator based at Texas Children’s Hospital and Baylor College of Medicine that supports pediatric device innovators nationwide throughout the pediatric device life cycle. The goal of the SWPDC is to accelerate commercialization and clinical use of novel pediatric devices.

PyrAmes is pleased to announce it has been awarded a Phase I grant from the National Institutes of Health. The Grant will be used for ongoing product development as well as clinical validation studies. A key objective of the NIH Grant Program is to facilitate development of promising medical technologies. The content of this announcement is solely the responsibility of the author and does not necessarily represent the official views of the NIH.

With hypertension reaching record levels, PyrAmes has joined with the Centers for Disease Control (CDC) in the formation of the National Hypertension Control Roundtable. The Roundtable was formed in 2020 along with 50 other organizations committed to reversing this trend. Nearly half of adults in the US suffer from hypertension, but only about 1 in 4 cases are well-managed. The US Surgeon General has issued a “Call to Action” to make hypertension control a national priority and to optimize patient care for hypertension.

PyrAmes is pleased to announce it has been awarded a Phase I grant from the United States Air Force (USAF) AFWERX program. Pyrames was part of a select group of companies asked to undertake a feasibility study to determine product viability within the Department of Defense (DoD). AFWERX is a program within the USAF and was formed in 2017 as a vehicle to fuel innovation within the private sector. The ultimate goal of the program is to address unmet needs and enhance the effectiveness of the Air Force.

Xina Quan, Co-founder and CEO of PyrAmes, accepted the One to Watch Award from Exponential Medicine. You can watch her acceptance presentation to the attendees starting at the 11:35 mark below. Exponential Medicine is an annual conference run by Singularity University, that provides leading scientists, inventors and thought leaders a forum to present and discuss the very latest in innovation. (more…)

At Ignite Healthcare Networks’ third annual Pitch Competition, PyrAmes was awarded a Texas HALO FUND Corona Award.  The 10-week mini-accelerator program featured eight women-led digital health startup companies from Texas, California and Australia, and provided support to the businesses through $220,000 in cash prizes and investments, as well as mentorship from industry experts, investors and potential customers.

PyrAmes was one of six pediatric device companies to win the “Make Your Medical Device Pitch for Kids!” program during the 7th Annual Pediatric Device Innovation Symposium. The program was developed to assist medical device companies in improving care in the Neonatal Intensive Care Unit (NICU). The Symposium is sponsored by Children’s National Hospital and the National Capital Consortium for Pediatric Device Innovation (NCC-PDI).

PyrAmes was selected by MedTech Innovator to participate in the 50 Best-in-Class Startups for 2019 Showcase and Accelerator from over 800 applicants.  The companies are part of an elite group of MedTech developers and will be featured at the Wilson Sonsini Goodrich & Rosati’s 27th Annual Medical Device Conference in San Francisco on June 21 and The MedTech Conference in Boston September 23-25.