The US Food and Drug Administration (FDA) has approved OxiWear’s ear-worn pulse oximeter, marking an advancement in wearable health technology.
The device is tailored for continuous, real-time blood oxygen saturation (SpO₂) and pulse rate monitoring, providing precision and convenience for users in motion or at rest, across all skin types, and in both clinical and home settings.
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It is designed to deliver uninterrupted oxygen saturation data, which is crucial for the early detection of hypoxemia, a condition characterised by low oxygen levels in the blood.
OxiWear’s technology offers life-saving potential through its emergency messaging alerts.
Designed for patient comfort and user-friendliness, the OxiWear device integrates seamlessly into daily life. Its non-intrusive, lightweight design ensures continuous monitoring without interfering with the wearer’s activities.
The device employs sensor technology and wireless capabilities, allowing for the transmission of data to healthcare providers for continuous evaluation and care management.
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By GlobalDataOxiWear 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 plans to increase its presence in the market for health monitoring technologies.
The company intends to advance its research and development to broaden the scope of its platform and cater to a wider array of health monitoring requirements.
Johns Hopkins University Hospital Division of Pulmonary and Critical Care Medicine associate professor Dr Panagis Galiatsatos said: “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.”
