Sibel Health, a digital health company, has announced another milestone with its ANNE® One continuous wearable monitoring solution receiving its 4th 510(k) clearance from the US Food and Drug Administration (FDA). 

This latest clearance expands the capabilities of the ANNE® One platform to include continuous ambulatory ECG monitoring, SpO2, temperature, and non-invasive blood pressure measurements. Furthermore, the clearance extends monitoring capabilities to individuals aged 12 and above in both home and hospital settings.

Steve Xu, MD, Co-Founder and CEO of Sibel Health, said, "Our mission here at Sibel Health is to deliver Better Health Data for All®. 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 particularly important to Sibel Health, a company founded on a strong commitment to pediatric medical device development. In 2021, Sibel Health was one of 5 innovation finalists in the National Capital Consortium for Pediatric Device Innovation funded by the FDA to support the 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. "We want to ensure that we offer advanced wireless monitoring for all pediatric patients from neonates to adolescents. This takes us one step closer," said Anne-Séverine Lima Pimenta, General Manager of Clinical Care at Sibel Health.

In conjunction with this achievement, Sibel Health has announced a strategic collaboration with Ann & Robert H. Lurie Children's Hospital of Chicago and its research enterprise, Stanley Manne Children's Research Institute. This collaboration aims to demonstrate the value of continuous monitoring in the home setting, particularly for children with medical complexity and disability.

Carolyn C. Foster, MD, MS, Assistant Professor of Pediatrics at Northwestern University Feinberg School of Medicine and Director of the Health@Home Digital Healthcare Research Initiative at Stanley Manne Children's Research Institute, expressed enthusiasm for the partnership, emphasizing the need for innovative technology solutions that are family-centric and address the unique needs of pediatric patients.

Supported by a philanthropic gift from Claire Cheney and Mark Ethier, founder of iZotope, to the Ann & Robert H. Lurie Children's Hospital of Chicago Foundation, this collaboration will further research in advanced wireless monitoring for children. Dr. Jeremy Wong, Assistant Professor of Pediatrics (Neurology and Epilepsy), highlighted the potential of this collaboration to enhance the care of neonates and children through next-generation neuromonitoring solutions.