US-based medical technology company Masimo has received the US Food and Drug Administration (FDA) 510(k) approval for connectivity of its Masimo W1 medical watch.
The FDA approval allows the medical watch to be integrated with the Masimo SafetyNet comprehensive telemonitoring solution.
Last year, the US FDA approved Masimo W1 Medical to provide continuous oxygen saturation (SpO2) and pulse rate (PR) for use at home and in hospitals.
Masimo said that the integration of W1 medical watch and SafetyNet telemonitoring solution enables accurate and reliable patient data, collected conveniently from the wrist.
The data will be made available on the fetyNet smartphone app and reviewed by remote caregivers, including by hospital clinicians on the web-based Masimo SafetyNet clinician portal.
Masimo founder and CEO Joe Kiani said: “For the first-time caregivers can get customised 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 the quality of care and ultimately improve outcomes for those they care for.”
Masimo W1 Medical Watch features an integrated Masimo MW-1 sensor, hardware, and software module with integrated optical sensors and electrocardiogram (ECG) electrode pads.
The module incorporates more than 30 years of Signal Extraction Technology pulse oximetry and rainbow Pulse CO-Oximetry knowledge into a single wearable module.
It also processes the signals using Masimo’s in-house signal processing algorithms to provide high-resolution SpO2, PR, perfusion index (Pi), and HR from an ECG.
The Masimo MW-1 watch continuously displays real-time data from the module on its touchscreen, in an easy-to-interpret format.
The Bluetooth connectivity allows patients to take full advantage of the Masimo SafetyNet app.
They can add new symptoms into CarePrograms using their phone, view their live data and trends, conduct virtual visits with clinicians, and view educational resources.
Also, clinicians at the hospital can manage their patients by examining data, trends, and customised notifications they receive within the Masimo SafetyNet clinician portal.
Furthermore, Masimo SafetyNet also connects to other wearables, such as Masimo Radius PPG for tetherless fingertip pulse oximetry and Radius Tº for continuous wireless thermometry.
Kiani added: “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.
“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.”
