FDA Clears Sibel Health’s Wireless Monitoring Platform for Newborns, Infants, Adults

Sibel Health’s ANNE One platform has received 501(k) clearance for continuous wireless hospital monitoring of babies of any gestational age for heart rate, skin temperature, and body temperature.

The platform also offers continuous monitoring to newborns, including those of extreme prematurity, up to 2 years of age, and for adults for additional physiological parameters such as respiratory rate, total sleep time, snoring, chest wall movement, body position and pulse rate.

The company noted that pediatric medical innovation remains a challenge as “the vast majority of medical devices used in pediatrics are not FDA-cleared or designed for children,” and hopes its collaboration with McGill University and Montreal Children’s Hospital to test the ANNE One platform will create the first neonatal intensive care unit to operate wirelessly.

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