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 provides 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.

The device’s clinical power 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 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. Managing oxygen levels can be prescribed for recovery after surgery, managing chronic breathing conditions, and for patients with congenital heart failure (CHF).

Moreover, 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.

“Clinicians at numerous prestigious institutions in Europe and the Middle East are already using Masimo W1 in a variety of innovative ways,” says Joe Kiani, founder and CEO of Masimo. “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.”

The Masimo W1 and the integrated Masimo MW-1 module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo MW-1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.