Sibel Health Receives FDA Approval for ANNE® One Continuous Monitoring Solution

Sibel Health announces the U.S. FDA 510(k) clearance of ANNE® One continuous neonatal and infant monitoring platform for babies born of any gestational age to infants of 2 years at the International Maternal Newborn Health Conference in Cape Town, South Africa.

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

Sibel Health recently closed a Series B financing round led by The Steele Foundation for Hope in 2022 with a mission to deliver Better Health Data for All®.

“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.

Sibel Health 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 The Montreal Children’s Hospital.

Ha Uk Chung PhD, VP of R&D and co-founder, notes “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.”

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.

Steve Xu MD, CEO and Co-founder at Sibel Health