FDA Clears OxiWear’s Real-Time Monitoring Device

OxiWear has gained U.S. Food and Drug Administration (FDA) clearance for its ear-worn oxygen monitoring device. 
 
The ear pulse oximeter is designed for continuous, real-time measurement of blood oxygen saturation (SpO₂) and pulse rate. This device provides unmatched accuracy and convenience while still and during motion, across all skin types, within clinical and home environments, according to the company. Unlike traditional methods, OxiWear ensures that patients and healthcare providers have constant access to important oxygen saturation data. The continuous data collection capability is vital for the early detection of hypoxemia (low oxygen levels), offering prompt haptic and emergency messaging alerts that can potentially save lives.
 
“We are thrilled to receive FDA clearance for our OxiWear device,” OxiWear CEO Shavini Fernando said. “This validation from the FDA underscores the rigorous testing and development that our team has undertaken to ensure the highest standards of safety and efficacy. Our goal is to provide a reliable, user-friendly solution that empowers patients and supports healthcare professionals in delivering optimal care.”
 
OxiWear’s device is designed with patient comfort and ease of use in mind. The lightweight, non-invasive wearable can be seamlessly integrated into daily life, providing continuous data collection without disrupting activities. It features advanced sensor technology and wireless connectivity, enabling data to be easily transmitted to healthcare providers for ongoing assessment and management.
 
“This device will save lives; both in the sense of picking up life-threatening hypoxemia, and ensuring the quality of life that so many patients lose when they need to monitor their oxygen level is preserved. For me, as a physician, recommending OxiWear has been a game changer for my patients, and watching them enjoy life as they monitor their oxygen levels confidently and responsibly, reaffirms my passion in medicine and doctoring,” stated Panagis Galiatsatos, M.D., associate professor of Medicine in the Division of Pulmonary & Critical Care Medicine at Johns Hopkins University Hospital. 
 
Arlington, Va.-based OxiWear is committed to reducing patient vulnerability to hypoxic injury through wearable, continuous blood oxygen measurement and low-oxygen alerting. Its mission is to increase safety and peace of mind for those prone to hypoxia, reduce healthcare costs, and save lives. OxiWear was developed in 2019 by Fernando, a VR/video game and web designer who suffers from pulmonary hypertension as a result of Eisenmenger’s syndrome.