Masimo has announced that the Masimo W1® medical watch has received FDA 510(k) clearance for connectivity, enabling its integration with the Masimo SafetyNet® telemonitoring solution.
This follows the earlier FDA clearance of the Masimo W1 Medical, the first medical watch to offer continuous monitoring of oxygen saturation (SpO2) and pulse rate (PR) for both home and hospital use.
With this new clearance, the Masimo W1 Medical can now connect to the Masimo SafetyNet system, allowing patient data collected from the wristwatch to be accessed via the Masimo SafetyNet app and reviewed by remote caregivers, including hospital clinicians through the Masimo SafetyNet clinician portal.
This development marks a significant advancement in health monitoring, as caregivers can now receive customized notifications based on data from the wrist-worn pulse oximeter, even in situations where in-person care is challenging.
The combination of Masimo W1 Medical and Masimo SafetyNet offers new possibilities for improving care quality and outcomes.
The Masimo W1 Medical’s clinical effectiveness stems from its Masimo MW-1 sensor, which incorporates decades of expertise in Signal Extraction Technology® and rainbow® Pulse CO-Oximetry.
The device features an optical sensor and ECG electrode pads to monitor physiological signals, processed through Masimo’s advanced algorithms to provide accurate data on SpO2, PR, perfusion index (Pi), and heart rate (HR).
The real-time data from the Masimo MW-1 module is displayed on the Masimo W1 watch, and with Bluetooth connectivity, patients can use the Masimo SafetyNet app to track their data, input symptoms, participate in virtual consultations with clinicians, and access educational resources.
Clinicians can review this data through the Masimo SafetyNet clinician portal, facilitating better management and care beyond the hospital setting.
This system also integrates with electronic medical records (EMRs) and supports detailed reporting. The Masimo SafetyNet cloud infrastructure ensures secure data transmission and storage with robust encryption, allowing access to patient data from any location.
This platform also connects with other Masimo devices, such as the Radius PPG® and Radius Tº®, enhancing its telemonitoring capabilities.
The Masimo W1 medical watch and Masimo MW-1 module are approved for use in hospitals, clinics, long-term care facilities, and homes for adult patients.