The wearable provides continuous, real-time measurement of blood oxygen saturation and pulse rate.
RT’s Three Key Takeaways:
- FDA Approves Ear-Worn Pulse Oximeter: OxiWear has received FDA clearance for its ear-worn pulse oximeter, which provides continuous, real-time monitoring of blood oxygen saturation and pulse rate, designed for use in both clinical and home environments.
- Early Hypoxemia Detection and Data Transmission: The device includes features such as haptic alerts for early hypoxemia detection and wireless connectivity for transmitting data to healthcare providers for ongoing assessment.
- Physician Highlights Device’s Impact: A physician from Johns Hopkins University Hospital noted the potential benefits of the OxiWear device for patients requiring continuous oxygen monitoring, emphasizing its role in detecting life-threatening hypoxemia.
Wearable health technology company OxiWear announced it has received clearance from the US Food and Drug Administration (FDA) for its ear-worn oxygen monitoring device.
OxiWear is an ear pulse oximeter designed for continuous, real-time measurement of blood oxygen saturation and pulse rate. This device is designed to provide accuracy and convenience while still and during motion, across all skin types, within clinical and home environments. The continuous data collection capability allows for the early detection of hypoxemia, offering haptic and emergency messaging alerts.
OxiWear’s device also features advanced sensor technology and wireless connectivity, enabling data to be transmitted to healthcare providers for ongoing assessment and management.
FDA Clearance
“We are thrilled to receive FDA clearance for our OxiWear device,” says Shavini Fernando, CEO of OxiWear, in a release. “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.”
Panagis Galiatsatos, MD, MHS, associate professor of medicine in the Division of Pulmonary & Critical Care Medicine at Johns Hopkins University Hospital, says in a release, “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.”
OxiWear says it is committed to continuing its research and development efforts to expand the capabilities of its platform and address a broader range of health monitoring needs.
Photo caption: OxiWear device bundle
Photo credit: OxiWear
