Masimo W1 medical watch receives FDA 510(k) clearance for OTC and prescription use

Masimo (NASDAQ: MASI) has announced the FDA 510(k) clearance of the Masimo W1 medical watch for both over-the-counter (OTC) and prescription use. This groundbreaking approval makes Masimo W1 the first FDA-cleared watch to provide continuous, real-time monitoring of oxygen saturation (SpO2) and pulse rate (PR).

Expanding the Reach of Masimo W1 in Medical Settings and Home Care

The FDA’s clearance broadens the use of Masimo W1 in the U.S., permitting its application in various settings such as hospitals, clinics, long-term care facilities, and home environments. The watch’s design is lifestyle-friendly and comfortable, allowing users to maintain untethered continuous pulse oximetry as they go about their daily activities.

Technological Innovation Behind Masimo W1

Masimo W1’s clinical efficacy stems from the integrated Masimo MW-1 sensor, which combines over 30 years of Masimo’s pulse oximetry knowledge. The sensor, along with the watch’s hardware and software, provides high-resolution data on SpO2, PR, perfusion index (Pi), and heart rate (HR) from an ECG.

Masimo W1 sets a new standard in medical wearables with FDA approval. Photo courtesy of Business Wire.

Real-Time Data Display and Patient Empowerment

The continuous data from the Masimo MW-1 module is displayed on the watch’s touchscreen in an easy-to-understand format, with alerts for abnormal SpO2 and PR levels. This feature can significantly aid in the management of oxygen levels for various patient conditions.

Global Acceptance and Clinical Applications

Joe Kiani, Founder and CEO of Masimo, highlighted the global use of Masimo W1, citing its adoption in Europe and the Middle East for various clinical applications, including patient discharge and preoperative assessments.

Broad Indications for the Masimo W1 Watch

In addition to continuous monitoring, the Masimo W1 and the Masimo MW-1 module are also suitable for spot-checking functional oxygen saturation and pulse rate, extending their utility in various adult healthcare settings.