OxiWear Receives FDA Clearance as a Medical Device

August 28, 2024 |

2 min read

Innovative Wearable Technology for Continuous Oxygen Measurements Set to Transform Patient Care

ARLINGTON, Va., Aug. 28, 2024 /PRNewswire/ -- OxiWear, a pioneering company in wearable health technology, is proud to announce that it has received clearance from the U.S. Food and Drug Administration (FDA) for its cutting-edge oxygen monitoring device. This certification marks a significant milestone in OxiWear’s mission to revolutionize patient care and enhance the quality of life for individuals with chronic diseases.

OxiWear is a cutting-edge ear pulse oximeter designed for continuous, real-time measurement of blood oxygen saturation (SpO₂) and pulse rate. This device provides unmatched accuracy and convenience while still and during motion, across all skin types, within clinical and home environments. Unlike traditional methods, OxiWear ensures that patients and healthcare providers have constant access to important oxygen saturation data. The continuous data collection capability is vital for the early detection of hypoxemia (low oxygen levels), offering prompt haptic and emergency messaging alerts that can potentially save lives.

“We are thrilled to receive FDA clearance for our OxiWear device,” said Shavini Fernando, CEO of OxiWear. “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’s device is designed with patient comfort and ease of use in mind. The lightweight, non-invasive wearable can be seamlessly integrated into daily life, providing continuous data collection without disrupting activities. It features advanced sensor technology and wireless connectivity, enabling data to be easily transmitted to healthcare providers for ongoing assessment and management.

Dr. Panagis Galiatsatos, MD, MHS, Associate Professor of Medicine in the Division of Pulmonary & Critical Care Medicine at Johns Hopkins University Hospital, 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.”

The FDA clearance paves the way for OxiWear to expand its market share for its innovative technology. The company 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.

About OxiWear:

OxiWear is committed to reducing patient vulnerability to hypoxic injury through wearable, continuous blood oxygen measurement and low-oxygen alerting. Our mission is to increase safety and peace of mind for those prone to hypoxia, reduce healthcare costs, and save lives. OxiWear was developed in 2019 by Shavini Fernando, a VR/video game and web designer who suffers from pulmonary hypertension as a result of Eisenmenger’s syndrome. For more information, visit:

https://www.oxiwear.com/.