The Northwestern University spinout has announced it has received a new FDA clearance for its ANNE One platform, to include continuous neonate and infant vital sign monitoring of babies at any gestational age to infants.
In 2021, Sibel Health received FDA 510(k) clearance for the ANNE One platform for vital sign monitoring via wearable sensors in adults, in a healthcare setting for clinical decision making.
The system, which is now FDA cleared for pediatric patients, allows for vital sign monitoring through clinical grade wearable sensors. The ANNE Limb for skin temperature and body temperature monitoring, and the ANNE Chest for heart rate, respiratory rate, step count, fall count and skin temperature monitoring.
Sibel also offers an app that gives caregivers insights into clinical data in real time.
The 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.
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