Masimo has secured 510(k) clearance from the US Food and Drug Administration for its W1 medical watch for connectivity, enabling integration with the Masimo SafetyNet telemonitoring solution.
The development follows the device's initial FDA clearance last year as the first medical watch for continuous oxygen saturation and pulse rate monitoring, both over-the-counter and prescription, in various settings.
The Masimo W1 medical watch's clinical capabilities stem from the integrated Masimo MW-1 sensor, which combines pulse oximetry and Pulse CO-Oximetry technologies into a wearable module.
It features an optical sensor and ECG electrode pads for detecting physiological signals, processed by Masimo's proprietary algorithms to deliver high-resolution data.
With Bluetooth connectivity, patients can now use the Masimo SafetyNet app to input symptoms, conduct virtual visits, view live data, and access educational resources.
Clinicians can monitor patient data remotely, receive custom notifications, and integrate medical data into electronic medical records (EMRs), enhancing patient management and care.
Masimo SafetyNet also allows data sharing with other caregivers while the Masimo SafetyNet cloud ensures secure data transmission and storage.
The Masimo W1 medical watch, along with the Masimo MW-1 module, is indicated for adult use in clinics, hospitals, long-term care facilities, and homes.
Masimo founder and CEO Joe Kiani said: “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.
“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 programmes 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 US, but we can allow regular people to take better care of each other.”
