The US Food and Drug Administration (FDA) granted 510(k) clearance to Sibel Health’s continuous neonatal and infant monitoring platform for babies born of any gestational age to infants of 2 years.

The Anne One platform is now cleared as a clinical-grade continuous monitoring solution for neonates, infants, and adults

The wearable vital-sign sensors offer a growing list of physiological parameters including heart rate, respiratory rate, skin temperature, body temperature, apnea-hypopnea index, total sleep time, snoring, chest wall movement, body position, pulse rate, peripheral arterial tonometry, and SpO2. 

“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,” says Sarah Coughlin, senior regulatory affairs and quality assurance engineer at Sibel Health, in a release. 

JooHee Lee, senior product manager and cofounder of Sibel Health, says in a release, “We see the Anne One system to be broadly applicable across the entire clinical care continuum from pediatrics to adults.” 

Sibel Health, a digital health company spun out of the Querrey Simpson Institute for Bioelectronics at Northwestern University, was founded on a commitment to serve the pediatric population, having won the 2020 Nature SpinOff Prize for its pioneering work in wirelessly monitoring premature neonates. 

Now, the company is announcing a deeper collaboration with Montreal Children’s Hospital and McGill University. 

“We’re already testing the Sibel system here with the vision to jointly create the world’s first wireless NICU. It’s especially exciting to now be able to offer a continuous wireless monitoring solution for sick kids born at any gestational age including extreme prematurity—particularly during a time where our pediatric hospitals are under so much pressure,” says Guilherme Sant’Anna, MD, PhD, neonatologist and principal investigator of the Smart Hospital Project at Montreal Children’s Hospital, in a release. 

Ha Uk Chung, PhD, vice president of research and development and cofounder, notes in the release, “It is satisfying to see what started off as my graduate student project at Northwestern University with publications in Science and Nature Medicine is now FDA-cleared and commercially launching in this special population. We’re looking forward to working with Dr. Sant’Anna in the Smart Hospital Project to bring wireless monitoring to neonates along with AI-driven clinical intelligence and neonatal-specific dashboards.”

Pediatric medical innovation remains a challenge. The vast majority of medical devices used in pediatrics are not FDA-cleared or designed for children, according to a release from the company. 

“At Sibel Health, pediatric medical device development has been and will always be a major focus for us. We know that going wireless will have the greatest impact for our littlest patients. The ability to announce our FDA-clearance and clinical performance data at the 2023 International Maternal Newborn Health Conference, a pivotal meeting convening the world’s experts maternal newborn health community, is especially rewarding given that the majority of neonatal deaths happen in low-income settings.” says Steve Xu, MD, CEO and cofounder of Sibel Health, in a release.

Photo caption: The Anne One wearable dual-sensor system for adult vital sign monitoring. The system has now been cleared for infants and neonates. 

Photo credit: Sibel Health / PR Newswire