Sibel Health’s continuous wearable monitoring solution, ANNE One, has received another 510(k) clearance from the U.S. FDA.
The ANNE One platform now allows for continuous ambulatory ECG monitoring, SpO2, temperature, and non-invasive blood pressure measurements. In addition, this new clearance extends the population to include individuals 12 years and above for monitoring in the home and hospital settings.
“Our mission here at Sibel Health is to deliver Better Health Data for All,” said Steve Xu. MD, co-founder and CEO of Sibel Health. “Our zero-cable wearable platform allows patients to be fully untethered while still being continuously monitored for all core vital signs whether you’re in the hospital or at home.”
The extension into the adolescent population is key for Sibel Health, which stated it has a commitment to pediatric medical device development. In 2021, Sibel Health was one of the finalists in the National Capital Consortium for Pediatric Device Innovation funded by the FDA to support advancement of pediatric medical devices. The next year Sibel Health received FDA clearance for ANNE Pediatrics – a miniaturized version of ANNE One—indicated for monitoring key vital signs in neonates including those born with extreme prematurity.
Sibel Health also announced a new collaboration with Ann & Robert H. Lurie Children’s Hospital of Chicago and its research enterprise, Stanley Manne Children’s Research Institute.
“We want to ensure that we offer advanced wireless monitoring for all pediatric patients from neonates to adolescents. This takes us one step closer,” says Anne-Séverine Lima Pimenta, general manager of clinical care at Sibel Health.