Masimo’s W1 medical watch has received U.S. Food and Drug Administration (FDA) 510(k) clearance for over-the-counter (OTC) and prescription (Rx) use.

Masimo的W1医疗手表已获得美国食品和药物管理局（FDA）510（k）的非处方（OTC）和处方（Rx）使用许可。

The company said W1 is the first FDA-cleared watch that offers continuous, real-time oxygen saturation (SpO2) and pulse rate (PR) for OTC and Rx use. The FDA nod broadens its indications in the U.S. as a medical devices for adults in hospitals, clinics, long-term care facilities, and at home.

该公司表示，W1是第一款FDA批准的手表，为OTC和Rx使用提供连续，实时的氧饱和度（SpO2）和脉率（PR）。FDA nod将其在美国的适应症扩大为医院，诊所，长期护理机构和家中成人的医疗器械。

The watch’s integrated MW-1 sensor, hardware, and software module incorporates over 30 years of Masimo’s Signal Extraction Technology (SET) pulse oximetry knowledge into a single wearable module. It has an optical sensor and electrocardiogram (ECG) electrode pads that detect physiological signals. The MW-1 module processes the signals using the company’s signal processing algorithms to output high-resolution SpO2, PR, perfusion index (Pi), and heart rate (HR) from an ECG. .

手表的集成MW-1传感器，硬件和软件模块将Masimo 30多年的信号提取技术（SET）脉搏血氧仪知识整合到一个可穿戴模块中。它具有检测生理信号的光学传感器和心电图（ECG）电极垫。MW-1模块使用公司的信号处理算法处理信号，从ECG输出高分辨率SpO2，PR，灌注指数（Pi）和心率（HR）。。.

Managing oxygen levels can be prescribed for recovery after surgery, managing chronic breathing conditions (e.g., COPD), and for patients with congenital heart failure (CHF).

管理氧气水平可以在手术后恢复，管理慢性呼吸状况（例如COPD）和先天性心力衰竭（CHF）患者。

The MW-1 module’s continuous data is shown in real time on the W1 watch touchscreen. To help identify low oxygen saturation, high pulse rate, or low pulse rate, the SpO2 and PR values are displayed in red when they fall outside normal ranges.

MW-1模块的连续数据在W1手表触摸屏上实时显示。为了帮助识别低氧饱和度，高脉率或低脉率，SpO2和PR值在超出正常范围时显示为红色。

Masimo founder and CEO Joe Kiani told the press, “Clinicians at numerous prestigious institutions in Europe and the Middle East are already using Masimo W1 in a variety of innovative ways. For example, Cambridge University Hospitals in England is using it to expand their Virtual Health program to support more confident patient discharge.

Masimo创始人兼首席执行官Joe Kiani向新闻界表示：“欧洲和中东众多着名机构的临床医生已经以各种创新方式使用Masimo W1。例如，英国的剑桥大学医院正在使用它来扩展他们的虚拟健康计划，以支持更自信的病人出院。

The Department of Anesthesiology at CHUV in Lausanne, Switzerland is using Masimo W1 on preoperative patients, to help anesthesiologists better understand the physiology and areas to improve for each patient they care for in the hospital, prior to surgery. We are excited about the hospital-to-home innovations the Masimo W1 can bring to the U.S, with this FDA clearance, and the empowerment of patients at home.” .

瑞士洛桑CHUV麻醉科正在对术前患者使用Masimo W1，以帮助麻醉医师在手术前更好地了解他们在医院照顾的每位患者的生理和需要改善的区域。我们对Masimo W1可以带到美国的医院到家庭创新感到兴奋，获得了FDA的批准，并赋予了家中患者的权力。”。.

The company also began a partnership for patient monitoring technology with GE HealthCare earlier this month.

本月早些时候，该公司还与GE HealthCare开始了患者监控技术的合作关系。