FDA Clears Masimo’s W1 Medical Watch for Connectivity to its SafetyNet Telemonitoring System

Masimo’s W1 medical watch has received U.S. Food and Drug Administration (FDA) 510(k) clearance for connectivity, allowing it to be integrated with the Masimo SafetyNet. 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.

“This is an important milestone for better health outcomes,” Masimo Founder/CEO Joe Kiani said. “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. 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 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. 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.”
 
The clinical power of Masimo W1 Medical comes from its integrated Masimo MW-1 sensor, hardware, and software module, which incorporates more than 30 years of 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 in an easy-to-interpret format. With the addition of Bluetooth connectivity, patients can now also take full advantage of the powerful 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.
 
In turn, clinicians back at the hospital or doctor’s office 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 valuable 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 more easily track patient progress, tailor remote care programs to match each patient’s needs, and streamline their workflows with high-fidelity reports, rich analytics, and the integration of reliable medical data into electronic medical records (EMRs).
 
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.
 
Making the secure transmission and storage of patient medical data possible for Masimo SafetyNet is the Masimo SafetyNet cloud: fast, scalable, and reliably available health cloud storage tailored to meet hospitals’ strict standards. The Masimo SafetyNet cloud provides the highest level of end-to-end encryption to ensure that data privacy and security are maintained, according to Masimo. In addition, the data set stored in the cloud can be used to generate robust, highly detailed reports.
 
Masimo SafetyNet also connects to other wearables, like Masimo Radius PPG for tetherless fingertip pulse oximetry, Radius Tº for continuous wireless thermometry, and a variety of spot-check devices.
 
The Masimo W1 medical watch and the integrated Masimo MW-1 module are best used for adults in hospitals, clinics, long-term care facilities, and homes.
 
Masimo is a global medical technology company that develops and produces various monitoring technologies, including measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, introduced in 1995, has been shown in more than 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET is estimated to be used on more than 200 million patients in hospitals and other healthcare settings worldwide,⁸ and is the primary pulse oximetry at all 10 top U.S. hospitals as ranked in the 2024 Newsweek World’s Best Hospitals listing.⁹ In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb), oxygen content (SpOC), carboxyhemoglobin (SpCO), methemoglobin (SpMet), Pleth Variability Index (PVi), RPVi (rainbow PVi), and Oxygen Reserve Index (ORi). In 2013, Masimo introduced the Root Patient Monitoring and Connectivity Platform, built to be flexible and expandable to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine Brain Function Monitoring, O3 Regional Oximetry, and ISA Capnography with NomoLine sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters includes devices designed for use in various clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7, Radius PPG, and Radius VSM, portable devices like Rad-67, fingertip pulse oximeters like MightySat Rx, and devices available for use both in the hospital and at home, such as Rad-97 and the Masimo W1 Medical Watch. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation platform, and include Iris Gateway, iSirona, Patient SafetyNet, Replica, Halo ION, UniView, UniView :60, and Masimo SafetyNet. Its growing portfolio of health and wellness solutions includes Radius Tº and Masimo W1 Sport. 
 
RPVi has not received FDA 510(k) clearance and is not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
 
References
¹ Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
² Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
³ de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
⁴ Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
⁵ Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
⁶ McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
⁷ McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
⁸ Estimate: Masimo data on file.
⁹ https://www.newsweek.com/rankings/worlds-best-hospitals-2024/united-states