OxiWear has gained U.S. Food and Drug Administration (FDA) clearance for its ear-worn oxygen monitoring device.

OxiWear的耳戴式氧气监测装置已获得美国食品和药物管理局（FDA）的批准。

The ear pulse oximeter is 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, according to the company. Unlike traditional methods, OxiWear ensures that patients and healthcare providers have constant access to important oxygen saturation data.

耳脉搏血氧仪设计用于连续、实时测量血氧饱和度（SpO2）和脉搏率。该公司表示，该设备在临床和家庭环境中，无论是静止还是运动时，在所有皮肤类型中都能提供无与伦比的准确性和便利性。与传统方法不同，OxiWear确保患者和医疗保健提供者能够不断获取重要的血氧饱和度数据。

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..

连续的数据收集功能对于早期检测低氧血症（低氧水平）至关重要，可提供及时的触觉和紧急信息警报，从而挽救生命。

'We are thrilled to receive FDA clearance for our OxiWear device,' OxiWear 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首席执行官沙维尼·费尔南多（ShaviniFernando）说，我们很高兴获得FDA对OxiWear设备的批准FDA的这一验证强调了我们团队为确保最高标准的安全性和有效性而进行的严格测试和开发。我们的目标是提供一个可靠、用户友好的解决方案，使患者能够提供最佳护理，并支持医疗保健专业人员。”。

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..

OxiWear的设备设计考虑到患者的舒适性和易用性。这种轻便、无创的可穿戴设备可以无缝集成到日常生活中，在不中断活动的情况下提供连续的数据收集。它采用先进的传感器技术和无线连接，使数据能够轻松传输到医疗保健提供商进行持续评估和管理。。

'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,' stated Panagis Galiatsatos, M.D., associate professor of Medicine in the Division of Pulmonary & Critical Care Medicine at Johns Hopkins University Hospital. .

；无论是从检测危及生命的低氧血症的意义上，还是从确保许多患者在需要监测其氧气水平时失去的生活质量的意义上来说，都是如此。约翰·霍普金斯大学医院肺与重症监护医学系医学副教授Panagis Galiatsatos医学博士表示，对我来说，作为一名医生，推荐OxiWear对我的患者来说是一个游戏规则的改变者，看着他们自信而负责任地监测他们的氧气水平，享受生活，重申了我对医学和医生的热情。。

Arlington, Va.-based OxiWear is committed to reducing patient vulnerability to hypoxic injury through wearable, continuous blood oxygen measurement and low-oxygen alerting. Its 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 Fernando, a VR/video game and web designer who suffers from pulmonary hypertension as a result of Eisenmenger's syndrome.  .

。它的使命是为那些容易缺氧的人增加安全和安心，降低医疗保健成本，挽救生命。OxiWear于2019年由费尔南多（Fernando）开发，费尔南多是一名VR/视频游戏和网页设计师，因艾森曼格综合征而患有肺动脉高压。。