Sibel Health receives FDA 510(k) for pediatric vital sign monitoring tool

Sibel Health, spun out of Northwestern University, announced it received a new FDA 510(k) clearance for its ANNE One platform to include continuous neonate and vital sign monitoring of infants born at any gestational age to of 2 years old.

The ANNE One platform allows for this vital sign monitoring via a clinical-grade wearable in two parts: the Anne limb, which measures skin and body temperature, and the Anne Chest, which monitors heart and respiratory rates, step count, fall count and skin temperature. 

Sibel also offers an integrated mobile software and cloud platform that gives caregivers insights into a patient’s clinical data in real time. 

The platform previously received FDA clearance for vital sign monitoring for adults in healthcare settings for clinical decision-making. 

The Chicago-based company also announced an extended collaboration with Montreal Children’s Hospital and McGill University in Canada. 

“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,” Dr. Guilherme Sant’Anna, neonatologist and principal investigator of the Smart Hospital Project at the Montreal Children’s Hospital, said in a statement.


In August, Sibel garnered $33 million in Series B funding, bringing its total raise to over $50 million.

Another company offering wireless pediatric monitoring is U.K.-based Isansys Lifecare. Its Patient Status Engine includes body-worn wireless ECG and respiratory sensors that collect continuous vital sign data.

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