May 10, 2023, Chicago /PRNewswire -- At the International Maternal Newborn Health Conference in Cape Town, South Africa, Sibel Health, an award-winning digital health business that was spun off from Northwestern University's Querrey Simpson Institute for Bioelectronics, announced a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for continuous neonatal and infant monitoring for infants born at any gestational age up to 2 years old. Now approved as a clinical-grade continuous monitoring system for newborns, babies, and adults, the ANNE® One platform. The Steele Foundation for Hope in 2022 and Sibel Health recently finalised a Series B investment round with the goal of delivering Better Health Data for All®.

Heart rate, respiration rate, skin temperature, body temperature, the apnea-hypopnea index, total sleep time, snoring, chest wall movement, body posture, pulse rate, peripheral arterial tonometry, and SpO2 are just a few of the physiological parameters that the ANNE® One platform can measure. According to Sarah Coughlin, senior regulatory affairs and quality assurance engineer at Sibel health, "We're thrilled to see that our technology can be used to monitor babies wirelessly born of any gestational age in the hospital for heart rate, skin temperature, and body temperature." JooHee Lee, senior product manager and cofounder of Sibel Health, continued, "We see the ANNE® One system as being broadly applicable across the entire clinical care continuum from paediatrics to adults."

After Sibel Health received the 2020 Nature SpinOff Prize for its groundbreaking work in remotely monitoring premature newborns, the company was established with a dedication on serving the paediatric community. The business is now promoting a closer partnership with McGill University and the Montreal Children's Hospital. "With the goal of collaboratively developing the first wireless NICU in the world, we are already testing the Sibel technology here. In a time when our paediatric hospitals are under so much stress, it's especially exciting to be able to offer a continuous wireless monitoring solution for sick children born at any gestational age, including extreme prematurity, says Guilherme Sant'Anna, MD, PhD, neonatologist and principal investigator of the Smart Hospital Project at The Montreal Children's Hospital. It is satisfying to see that the study I started as a graduate student at Northwestern University, which resulted in articles in Science and Nature Medicine, is now FDA-cleared and making its commercial debut in this particular population, says Ha Uk Chung, PhD, VP of R&D and cofounder. We're excited to collaborate with Dr. Sant'Anna on the Smart Hospital Project to provide newborns with wireless monitoring, AI-driven clinical intelligence, and dashboards tailored specifically for neonates.

Innovation in paediatric medicine is still a struggle. Most medical equipment utilised in paediatrics is neither FDA-cleared nor created with kids in mind. "Developing paediatric medical devices has always been a top priority for us at Sibel Health, and it always will be. We are confident that switching to wifi will benefit our youngest patients the most. Given that the majority of neonatal deaths take place in low-income settings, the opportunity to present our FDA-clearance and clinical performance data at the 2023 International Maternal Newborn Health Conference is particularly rewarding, according to Steve Xu, MD, CEO and Cofounder.

Source prnewswire