Sibel Announces its 4th FDA Clearance for Continuous Wearable Vital Signs Monitoring with ANNE® One and Additional Strategic Collaboration with Ann & Robert H. Lurie Children's Hospital of Chicago

Expanded Indication Includes Adolescents, Ambulatory ECG, Continuous SpO₂, and Non-Invasive Blood Pressure in the Home or Hospital Setting.

CHICAGO, Feb. 7, 2024 /PRNewswire/ -- Sibel Health, a leading digital health company, announced today that its continuous wearable monitoring solution, ANNE® One, has received another 510(k) clearance from the U.S. Food and Drug Administration (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.

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 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," says Anne-Séverine Lima Pimenta, General Manager of Clinical Care at Sibel Health.

Sibel Health also announces a new collaboration with Ann & Robert H. Lurie Children's Hospital of Chicago and its research enterprise, Stanley Manne Children's Research Institute. "We're pleased to be working with Sibel Health, a startup right in our own backyard, to demonstrate the value of continuous monitoring in the home setting. The needs of children with medical complexity and disability require new technology solutions that are family centric and innovative," says 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. This collaboration is further supported by a major philanthropic gift to the Ann & Robert H. Lurie Children's Hospital of Chicago Foundation, from Claire Cheney and Mark Ethier, founder of iZotope. This gift will enable Sibel Health and Lurie Children's to expand its collaboration to other avenues of research in advanced wireless monitoring for children with Dr. Jeremy Wong, Assistant Professor of Pediatrics (Neurology and Epilepsy). "I have had the pleasure of working with Sibel on their next generation neuromonitoring solutions over the last two years. I am excited for the opportunity to leverage Claire and Mark's generosity to further this collaboration to greater heights to enhance the care of neonates and children" says Dr. Wong.

About Sibel Health:
Sibel Health is an award-winning digital health company with a mission to deliver Better Health Data for All®. Based in Chicago with an international office in Seoul, the company's FDA-cleared ANNE® platform includes advanced wearable sensors, AI-enabled data analytics, and an integrated mobile software and cloud platform. Sibel's partnerships include some of the most respected healthcare organizations worldwide. For more information, please visit us at www.sibelhealth.com and follow us on LinkedIn.

About Lurie Children's:
Research at Ann & Robert H. Lurie Children's Hospital of Chicago is conducted through Stanley Manne Children's Research Institute. Manne Research Institute is focused on improving child health, transforming pediatric medicine, and ensuring healthier futures through the relentless pursuit of knowledge. Lurie Children's is a nonprofit organization committed to providing access to exceptional care for every child. It is ranked as one of the nation's top children's hospitals by U.S. News & World Report. Lurie Children's is the pediatric training ground for Northwestern University Feinberg School of Medicine.

SOURCE Sibel Health