Sibel Health has received a new 510(k) clearance from the US Food and Drug Administration (FDA) for new indications of its ANNE One platform.
Its latest clearance is intended for continuous neonatal and infant monitoring for babies born of any gestational age to infants of two years.
The ANNE One platform has now received clearance as a clinical-grade continuous monitoring solution suitable for neonates, infants and adults.
The platform comprises advanced wearable sensors, artificial intelligence-enabled data analytics and an integrated mobile software and cloud platform.
It offers several physiological parameters including heart rate, skin temperature, respiratory rate, body temperature and apnea-hypopnea index.
Other parameters include total sleep time, snoring, chest wall movement, body position, pulse rate, peripheral arterial tonometry and SpO₂.
Sibel Health CEO and co-founder Dr Steve Xu said: “At Sibel Health, paediatric medical device development has been and will always be a major focus for us. We know that going wireless will have the greatest impact on our littlest patients.
“The ability to announce our FDA-clearance and clinical performance data at the 2023 International Maternal Newborn Health Conference, a pivotal meeting convening the world’s experts in the maternal newborn health community, is especially rewarding given that the majority of neonatal deaths happen in low-income settings.”
Sibel Health, a digital health company, was established as a separate entity emerging from Northwestern University’s Querrey Simpson Institute for Bioelectronics.