OxiWear has achieved a significant milestone by receiving clearance from the U.S. Food and Drug Administration (FDA) for its innovative oxygen data collection device. This wearable technology, designed for continuous and real-time measurement of blood oxygen saturation (SpO2) and pulse rate, is set to significantly impact patient care, especially for individuals with chronic diseases.
Rachel Penney, who lives with Pulmonary Fibrosis and Raynaud’s, utilizes OxiWear to monitor her blood oxygen levels. Unlike traditional methods, the device offers unmatched accuracy and convenience whether the user is still or in motion, and it works effectively across all skin types in both clinical and home settings. Continuous data collection by OxiWear allows for early detection of low oxygen levels, providing prompt haptic and emergency messaging alerts that can potentially save lives.
Shavini Fernando, CEO of OxiWear, expressed her excitement over the FDA clearance, highlighting the rigorous testing and development that went into ensuring the device meets the highest standards of safety and efficacy. She emphasized that the goal is to provide a user-friendly, reliable solution that empowers patients and supports healthcare professionals in delivering optimal care.
The device is designed for comfort and ease of use, being lightweight and non-invasive, making it easy to incorporate into daily life without disruption. It employs advanced sensor technology and wireless connectivity, allowing data to be easily transmitted to healthcare providers for continuous assessment and management.
Dr. Panagis Galiatsatos, Associate Professor of Medicine in the Division of Pulmonary & Critical Care Medicine at Johns Hopkins University Hospital, noted that the device is life-saving. It not only detects low oxygen levels but also maintains the quality of life for patients who need to monitor their oxygen levels regularly. He remarked that recommending OxiWear to his patients would be transformative, as it enables them to measure their oxygen levels confidently and responsibly.
The FDA clearance allows OxiWear to broaden its market reach. The company remains committed to advancing its research and development efforts to expand its platform capabilities and address a wider range of health monitoring needs.
OxiWear aims to enhance patient safety by offering continuous blood oxygen measurement and low-oxygen alerting. The company was founded in 2019 by Shavini Fernando, who developed the device due to her own experience with pulmonary hypertension resulting from Eisenmenger’s syndrome.
