Masimo W1 Medical Watch Receives FDA 510(k) Clearance for Connectivity to the Masimo SafetyNet Telemonitoring System

Masimo (NASDAQ: MASI) today announced that the Masimo W1 medical watch has received FDA 510(k) clearance for connectivity, allowing it to be integrated with the Masimo SafetyNet comprehensive telemonitoring solution. Masimo W1 Medical received FDA clearance last year as the first medical watch to provide continuous oxygen saturation (SpO₂) and pulse rate (PR) for over-the-counter and prescription use at home and in hospitals. The combination of Masimo W1 Medical and Masimo SafetyNet allows accurate and reliable patient data, collected conveniently and comfortably via the wrist, to be made available on the Masimo SafetyNet smartphone app and reviewed by remote caregivers, including by hospital clinicians on the web-based Masimo SafetyNet clinician portal – anywhere and at any time.

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Masimo W1 with Masimo SafetyNet (Photo: Business Wire)

Joe Kiani, Founder and CEO of Masimo, said, “This is an important milestone for better health outcomes. For the first time caregivers can get customized notifications, based on data from an unobtrusive pulse oximeter worn on the wrist of a patient or loved one, in situations where it’s logistically difficult to provide care in person. Masimo W1 Medical with Masimo SafetyNet opens up a world of possibilities for caregivers looking to improve quality of care and ultimately improve outcomes for those they care for.”

Mr. Kiani continued, “We’ve been excited to see how institutions in Europe and the Middle East are already integrating Masimo W1 with Masimo SafetyNet into their practices in a variety of innovative ways, such as programs that support more confident patient discharge, help anesthesiologists better understand each patient’s unique physiology prior to surgery, and drive toward more predictive, rather than reactive, models of care. And now, with this FDA clearance, we can not only bring these capabilities to the U.S., but we can allow regular people to take better care of each other.”

The clinical power of Masimo W1 Medical comes from its integrated Masimo MW-1 sensor, hardware, and software module, which incorporates over 30 years of Signal Extraction Technology pulse oximetry and rainbow Pulse CO-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 SpO_2, PR, perfusion index (Pi), and HR from an ECG.