Masimo W1™ Medical Watch receives FDA clearance for OTC and prescription use

November 21, 2023- Masimo announced that the Masimo W1™ medical watch has received FDA 510(k) clearance for over-the-counter (OTC) and prescription use (Rx).  Masimo W1 is the first FDA-cleared watch to provide continuous real-time oxygen saturation (SpO2) and pulse rate (PR) for OTC and Rx use. The FDA clearance expands the indications for the Masimo W1 in the U.S. as a medical device for use by adults in hospitals, clinics, long-term care facilities, and in the home. Developed to be comfortable and lifestyle-friendly, the Masimo W1 medical watch empowers users with untethered continuous pulse oximetry as they move about their lives – no matter where they are.

The clinical power of the Masimo W1 comes from its integrated Masimo MW-1 sensor, hardware, and software module, which incorporates over 30 years of Signal Extraction Technology® pulse oximetry knowledge into a single wearable module. It has an integrated optical sensor and electrocardiogram (ECG) electrode pads that can be used to detect physiological signals. The Masimo MW-1 module also processes these signals using Masimo’s proprietary signal processing algorithms to output high-resolution SpO2, PR, perfusion index (Pi), and heart rate (HR) from an ECG. The continuous pulse oximetry data, under the care of a physician, can give greater visibility of changes in oxygen saturation to help patients better manage their oxygen levels daily.

The continuous data from the Masimo MW-1 module is displayed in real-time on the Masimo W1 watch touchscreen in an easy-to-interpret format. To help individuals identify low oxygen saturation, high pulse rate, or low pulse rate, the SpO2 and PR values are displayed in red when they fall outside of their normal ranges. 

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