Masimo Receives FDA Clearance for Groundbreaking Wearable

Masimo, a global leader in non-invasive monitoring technologies, has achieved a significant milestone with the FDA granting 510(k) clearance for its groundbreaking medical watch, the Masimo W1. This clearance allows both over-the-counter and prescription use of the watch, marking a major advancement in continuous monitoring capabilities for real-time oxygen saturation (SpO2) and pulse rate.

The Masimo W1 stands out as the first FDA-cleared watch designed to provide continuous monitoring for both general and medical use. This clearance allows individuals to utilize the watch in diverse settings, including hospitals, clinics, long-term care facilities, and home environments. The news of the FDA clearance has propelled Masimo shares up over 1% to $94.75 apiece, signaling a positive market response to this innovative development.

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The Masimo W1's capabilities are made possible through its integrated Masimo MW-1 sensor, hardware, and software module. This module incorporates over 30 years of Signal Extraction Technology pulse oximetry knowledge into a single wearable device. The watch features an integrated optical sensor and electrocardiogram (ECG) electrode pads, enabling the detection of crucial physiological signals.

Further, Masimo CEO Joe Kiani highlighted the watch's impact in Europe and the Middle East, where clinicians at prestigious institutions have been using the Masimo W1 for various innovative applications. For instance, Cambridge University Hospitals in England leverage the watch to enhance their virtual health program, while the Department of Anesthesiology at CHUV in Lausanne, Switzerland, uses it on preoperative patients to better understand their physiology and areas for improvement before surgery.

The MW-1 module uses Masimo's own signal processing algorithms to get high-resolution readings of SpO2, pulse rate, perfusion index (Pi), and heart rate (HR) from an ECG. This continuous pulse oximetry data, when under the supervision of a physician, provides enhanced visibility into changes in oxygen saturation, aiding patients in managing their oxygen levels daily.

Moreover, Masimo envisions various applications for the watch, including recovery after surgery, managing chronic breathing conditions like COPD, and supporting patients with congenital heart failure. The watch's real-time data display on its touchscreen highlights abnormal SpO2 and pulse rate values in red, facilitating the swift identification of potential issues.

This FDA clearance underscores Masimo's commitment to advancing non-invasive monitoring technologies and providing valuable tools for both healthcare professionals and individuals. The Masimo W1's integration of cutting-edge technology into a wearable device represents a significant leap forward in continuous monitoring capabilities, with potential implications for improving patient outcomes and healthcare management.