Sibel Health, a digital health company spun out of the Querrey Simpson Institute for Bioelectronics at Northwestern University, has secured a new 510(k) clearance from the US Food and Drug Administration (FDA) for its ANNE One platform.
The ANNE One platform is now authorised as a clinical-grade continuous monitoring solution for neonatal and infant monitoring for babies born of any gestational age to infants of two years.
According to Sibel Health, the platform provides a range of physiological parameters like skin temperature, heart rate, respiratory rate, body temperature, apnea-hypopnea index, total sleep time, snoring, chest wall movement, body position, pulse rate, SpO2 and peripheral arterial tonometry.
Additionally, the digital health company announced a research collaboration with McGill University and Montreal Children’s Hospital.
Under the partnership, the Montreal Children’s Hospital will test the Sibel system’s sensors to develop the world’s first wireless neonatal intensive care unit (NICU).
Sibel Health senior regulatory affairs and quality assurance engineer Sarah Coughlin said: “We’re excited to see that our technology can be used to monitor babies wirelessly born of any gestational age in the hospital for heart rate, skin temperature, and body temperature.”
The digital health company said its FDA-cleared ANNE platform has advanced wearable sensors, AI-enabled data analytics, and an integrated mobile software and cloud platform.
The platform is now said to be a comprehensive solution for home sleep diagnostics and continuous patient monitoring for neonates, infants, and adults.
Sibel Health CEO and cofounder 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 for our littlest patients.”
In August 2022, the company closed a $33m Series B financing round to advance ANNE One platform for home and hospital monitoring through global partnerships.
