Sibel Health announced it received new FDA 510(k) clearance for its ANNE One platform on May 10, 2023. The platform has now received clearance as a clinical-grade, continuous wireless monitoring solution for neonates, infants and adults.
About ANNE One
The ANNE One platform leverages advanced wearable sensors and artificial intelligence-enabled data analytics for remote patient monitoring. It allows medical professionals to continuously monitor vital signs and identify predictive analysis, according to the company.
The system monitors 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 oxygen saturation.
With soft and flexible sensors, ANNE One remotely monitors babies born of any gestational age, including extreme prematurity, infants and adults.
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