Sibel Health, a medical technology company spun out of the Querrey Simpson Institute for Bioelectronics at Northwestern University, announces that the U.S. FDA has granted 510(k) clearance to the ANNE One platform. The ANNE One platform is a wireless, flexible, and rechargeable monitoring system indicated for the measurement of multiple vital signs in the healthcare setting for clinical decision-making by medical providers for patients 18 years or older. It includes a companion mobile device pre-loaded with ANNEView software to visualize clinical data in real time.
Prior to the FDA clearance, the ANNE One system has been deployed extensively in thousands of patients across a wide range of geographic locations including low-resource settings with scientific publications in Nature Medicine, Lancet Digital Medicine, and Proceedings of the National Academy of Medicine. With U.S. government support, Sibel Health has also deployed the ANNEOne platform to assess patients with COVID-19.
“It’s so rewarding to see a cutting-edge technology go from scientific and technical proof of concept to FDA clearance—a hugely important milestone as we deploy ANNE One clinically,” says Ha Uk Chung PhD, cofounder and vice president of research and development at Sibel Health.
Jong Yoon Lee, cofounder and vice president of software engineering, also spoke out about the clearance, adding: “The ability for our system to monitor a wide range of vital signs using a dual-sensor platform is very powerful and unique. The interoperability and the extendability of the system will allow us to use this approval as a foundation to expand to other novel indications and make monitoring accessible to everyone.”
Featured image: ANNE One wearable dual-sensor system for adult vital sign monitoring.