Sibel Healtha Northwestern University spin-off, announced that it has received new FDA 510(k) clearance for its ANNE One platform, to include continuous monitoring of neonatal and infant vital signs of babies at any gestational age through for 2 year old infants.
The ANNE One platform enables monitoring of vital signs via a clinical-grade wearable device that consists of two parts: Anne limb, which measures skin and body temperature, and Anne Chest, which monitors heart rates and respiratory rate, number of steps, number of falls and skin temperature. .
Sibel also offers integrated mobile software and a cloud platform that gives caregivers insight into a patient’s clinical data in real time.
The platform before has received FDA clearance for monitoring adult vital signs in healthcare settings for clinical decision making.
The Chicago-based company also announced an expanded collaboration with the Montreal Children’s Hospital and McGill University in Canada.
“We are already testing the Sibel system here with the vision of jointly creating the world’s first wireless neonatal unit. It is particularly exciting to now be able to offer a continuous wireless monitoring solution for sick children born at any gestational age. , including extreme prematurity, especially during a time when our pediatric hospitals are under so much pressure,” said Dr. Guilherme Sant’Anna, Neonatologist and Principal Investigator of the Smart Hospital Project at The Montreal Children’s Hospital , in a press release. You
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In August, Sibel harvested $33 million in Series B fundingbringing his total raise to more than $50 million.
Another company offering wireless pediatric monitoring is based in the UK Isansys Lifecare. Its patient status engine includes a body-worn wireless ECG and respiratory sensors that continuously collect vital signs data.