OxiWear granted US FDA clearance as a medical device for blood oxygen monitoring
A cutting-edge blood oxygen monitoring device, which can monitor real-time blood oxygen saturation and pulse rate has been given the green light by the US FDA.
Early detection of low oxygen levels is important for preventing brain or cardiovascular damage. OxiWear (VA, USA) has become the first wearable device for measuring continuous blood oxygen levels and pulse rate to be cleared by the FDA. The ear-worn, wireless device is designed with everyday life in mind; patients can use it while stationary or in motion. The device is also accessible as it can be used across all skin types and can be used comfortably at home or in a clinical setting.
The device supplies healthcare providers with readings of hypoxemia, offering patients remote assessment. Through this blood oxygen monitoring technology, patients with chronic diseases who are at increased risk of hypoxemia have access to important blood oxygen saturation data. Ongoing monitoring will allow better detection of life-threatening hypoxemic events and life-saving support through emergency messaging alerts.
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Panagis Galiatsatos from Johns Hopkins University Hospital (MD, USA) stated, “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.”
Shavini Fernando, CEO of OxiWear, commented, “We are thrilled to receive FDA clearance for our OxiWear device. 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.”
