The Masimo W1 medical watch, now FDA-cleared for integration with Masimo SafetyNet, enables continuous remote monitoring of vital signs.


RT’s Three Key Takeaways:

  1. FDA Clearance for Connectivity: The Masimo W1 medical watch has received FDA 510(k) clearance for integration with the Masimo SafetyNet telemonitoring solution, enabling enhanced remote monitoring and data sharing between patients and clinicians.
  2. Enhanced Remote Care: With this integration, caregivers can now access real-time patient data, receive customized notifications, and manage care remotely.
  3. Monitoring Solution: The Masimo W1 watch, combined with Masimo SafetyNet, allows for continuous tracking of vital signs, including oxygen saturation and pulse rate, while also supporting broader remote care programs that can be tailored to individual patient needs.

Masimo announced that the Masimo W1 medical watch has received FDA 510(k) clearance for connectivity, allowing it to be integrated with the Masimo SafetyNet 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 patient data, collected 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.

“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,” says Joe Kiani, founder and CEO of Masimo, in a release. “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.”

Masimo W1 Medical Watch

The clinical power of Masimo W1 Medical comes from its integrated Masimo MW-1 sensor, hardware, and software module, which incorporates 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 SpO2, PR, perfusion index (Pi), and HR from an ECG.

The continuous data from the Masimo MW-1 module is displayed in real time on the Masimo W1 watch touchscreen. With the addition of Bluetooth connectivity, patients can now also take advantage of the Masimo SafetyNet app, using their phone to input additional symptoms into CarePrograms designed by their clinicians, view their live data and trends, conduct virtual visits with clinicians, and view educational resources.

Masimo SafetyNet Clinician Portal

In turn, clinicians can examine data and trends and receive customized notifications within the Masimo SafetyNet clinician portal—enabling care providers to manage their patients beyond the boundaries of the hospital. With Masimo SafetyNet, clinicians gain insight into how their patients’ physiological data changes as they go about their day, helping them better understand their patients so that they can identify and prioritize patients who need follow-up. 

They can track patient progress, tailor remote care programs to match each patient’s needs, and streamline their workflows with reports, analytics, and the integration of medical data into electronic medical records.

In addition to making patient data available to hospital clinicians via the clinician portal, patients can configure Masimo SafetyNet so that their data can be shared with other types of caregivers, such as a family member taking care of their elderly parents or a loved one. Remote caregivers can also receive customized updates, helping better assess when to check in with their loved one.

Enhancing Remote Patient Monitoring

“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,” says Kiani in a release. “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.”

Making the secure transmission and storage of patient medical data possible for Masimo SafetyNet is the Masimo SafetyNet cloud, which provides end-to-end encryption to ensure that data privacy and security are maintained and gives clinicians access to trended patient data and waveforms. 

Masimo SafetyNet also connects to other wearables, like Masimo Radius PPG for tetherless fingertip pulse oximetry and Radius Tº for continuous wireless thermometry, as well as a variety of spot-check devices.

The Masimo W1 medical watch and the integrated Masimo MW-1 module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.

Photo caption: Masimo W1 with Masimo SafetyNet

Photo credit: Business Wire