30 Aug 2024

FDA Approves OxiWear for Real-Time Blood Oxygen Monitoring

OxiWear has received FDA clearance for its innovative ear pulse oximeter, designed to continuously monitor blood oxygen saturation (SpO2) and pulse rate in real-time. This device offers accurate readings even during movement and across all skin types, making it suitable for both clinical and home environments. By providing continuous data collection, OxiWear helps detect early signs of hypoxemia, with haptic and emergency alerts potentially saving lives.


The lightweight, non-invasive design of OxiWear ensures patient comfort while allowing seamless integration into daily life. Its advanced sensor technology and wireless connectivity enable ongoing assessment by healthcare providers, enhancing patient care. Dr. Panagis Galiatsatos from Johns Hopkins University Hospital highlighted the device's life-saving potential and its impact on improving patient quality of life.


With FDA clearance, OxiWear is set to expand its market presence, focusing on reducing patient vulnerability to hypoxic injury and enhancing safety for those at risk of low oxygen levels. Founded by Shavini Fernando, who developed the device due to her own experience with pulmonary hypertension, OxiWear aims to revolutionize health monitoring and improve patient outcomes.


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