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Continuous Neonatal and Infant Monitoring Solution to Pave Way for World's First Wireless NICU
The continuous tracking of vital signs and other biological indicators in the Neonatal Intensive Care Unit (NICU) typically involves the use of sensors wired to bedside monitors. This setup poses several challenges, such as potential skin damage or infection, entanglement risks around the infant's body, and wire damage that could hinder routine care. Additionally, the presence of these cables and wires can interfere with parent-infant interaction and skin-to-skin contact. Now, an advanced solution for wireless monitoring in neonates and infants could help meet the challenges of pediatric monitoring.
Sibel Health’s (Chicago, IL, USA) ANNE One platform is a clinical-grade continuous monitoring solution for neonates, infants, and adults. This platform provides an expanding range of physiological parameters, including heart rate, respiratory rate, skin and body temperature, apnea-hypopnea index, total sleep time, snoring, chest wall movement, body position, pulse rate, peripheral arterial tonometry, and SpO2.
Most medical devices utilized in pediatrics are neither designed specifically for children nor cleared by the U.S. Food and Drug Administration (FDA). However, the ANNE One platform has earned a new 510(k) clearance from the U.S. FDA for continuous neonatal and infant monitoring for babies of any gestational age up to two years. Now, the company has entered into a deeper collaboration with Montreal Children's Hospital (Quebec, Canada) and McGill University (Montreal, Canada) to test the platform with the aim of creating the world's first wireless NICU.
"We're excited 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," noted Sarah Coughlin, Senior Regulatory Affairs and Quality Assurance Engineer at Sibel Health.
"We see the ANNE One system to be broadly applicable across the entire clinical care continuum from pediatrics to adults," added JooHee Lee, Senior Product Manager and co-founder of Sibel Health.
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