Masimo (NASDAQ: MASI) has announced that the Masimo W1® medical watch has received FDA 510(k) clearance for integration with the Masimo SafetyNet® telemonitoring system. The Masimo W1®—the first medical watch to offer continuous oxygen saturation (SpO2) and pulse rate (PR) monitoring—can now seamlessly connect with Masimo SafetyNet. This integration allows patient data collected via the wrist to be accessed on the Masimo SafetyNet app or reviewed by clinicians through a web-based portal.
Joe Kiani, CEO of Masimo, noted, “This milestone enhances health outcomes by enabling caregivers to receive notifications based on wrist-worn pulse oximeter data, improving care in challenging logistics. This integration opens new possibilities for enhancing care quality and outcomes.”
Kiani added that Masimo W1 has already been successfully implemented in Europe and the Middle East, supporting various applications from patient discharge to pre-surgery assessments. With FDA clearance, these capabilities can now extend to the U.S., allowing for improved personal and remote care.
The Masimo W1 features the Masimo MW-1 sensor, which integrates advanced pulse oximetry and rainbow® Pulse CO-Oximetry technologies. The device provides real-time data on its touchscreen and connects via Bluetooth to the Masimo SafetyNet app for enhanced functionalities like symptom tracking, virtual visits, and educational resources.
Clinicians can monitor patient data through the Masimo SafetyNet clinician portal, offering insights into daily physiological changes and enabling better patient management. The secure Masimo SafetyNet cloud ensures data privacy and supports detailed reporting and analysis, making it a comprehensive population health management tool.
Masimo SafetyNet also integrates with other devices, such as the Masimo Radius PPG® and Radius Tº® for additional monitoring capabilities. The Masimo W1 and MW-1 module are designed for use in hospitals, clinics, long-term care facilities, and homes.
