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MagyarOxiWear receives FDA clearance for continuous blood oxygen ear clip that works even during motion
OxiWear has received FDA clearance for its continuous blood oxygen monitor that works even during motion. Other monitors can only measure accurately when users are at rest or are not FDA-cleared as a medical device for accuracy and safety. The ear-wearable alerts the user to low oxygen levels and can call emergency services.
Smartwatches such as the Apple Watch have been found to be inaccurate. In a review of five publications, blood oxygen saturation (SpO2) measurements of the Watch varied +/- 2.7 to 5.9%, with outliers as much as 15%. For patients suffering from heart and lung diseases, this degree of oxygen reduction (hypoxia) can result in blackouts and death because their bodies already receive diminished amounts of oxygen. This was the motivating reason for founder Shavini Fernando, who suffers from severe pulmonary hypertension, to create OxiWear.
The ear-wearable is the only FDA-cleared device that can measure blood oxygen saturation while the user is sitting or in motion. Other monitors can only measure accurately when the patient is at rest. The OxiWear monitor can continuously monitor SpO2 levels to detect pending emergencies and alert the wearer of dropping levels by vibrating. As necessary, the device will automatically notify designated emergency contacts by text in addition to contacting 911 emergency services.
The mobile app for Android and Apple smartphones provides live, continuous health tracking of blood oxygen saturation (SpO2), heart rate (bpm), altitude, humidity, barometric pressure, and air quality. This allows users to better understand the environmental triggers for health episodes. The alert threshold for oxygen can be set between 92% to 97%. Reports with five hours of oxygen data can be downloaded or emailed for premium subscribers. OxiWear does not need to be connected to the mobile app to operate and detect low blood oxygen levels.
The OxiWear bundle package has a $500.00 MSRP (available here on Amazon). The package includes the ear wearable, a charger case, three adjustment pads, and a charger cable. An optional charging case with a $175.00 MSRP provides two extra charges for a total runtime of 24-hours for the OxiWear. A set of interchangeable faceplates with a $49.99 MSRP allows users to customize the color of their OxiWear. The water-resistant monitor can be disinfected with alcohol wipes.
Source(s)
OxiWear Receives FDA Clearance as a Medical Device
OxiWear (PRNewsfoto/OxiWear)
News provided by OxiWear
Aug 28, 2024, 10:10 ET
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 data collection 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.
Rachel Penney, living with Pulmonary Fibrosis and Raynaud's, uses OxiWear to measure her blood oxygen levels.
OxiWear Device Bundle
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 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 low oxygen levels, and ensuring the quality of life that so many patients lose when they need to measure their oxygen level is preserved. For me, as a physician, recommending OxiWear will be a game changer for my patients, and watching them enjoy life as they measure 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 low oxygen levels through wearable, continuous blood oxygen measurement and low-oxygen alerting. Our mission is to increase safety and peace of mind for those prone to low oxygen levels, 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:
SOURCE OxiWear
