Masimo announces FDA 510(k) clearance of Radius VSM™

Masimo announced that Radius VSM™, a patient-worn, continuous multi-parameter vital signs monitor, has received FDA 510(k) clearance. Designed on a modular platform, Radius VSM allows clinicians to monitor a wide variety of physiological measurements, including Masimo SET® pulse oximetry, noninvasive blood pressure, temperature, respiration rate, and electrocardiography (ECG). By combining the reliability and accuracy of larger bedside monitors with the comfort and freedom of a wearable device, Radius VSM allows ambulation and movement while ensuring patients remain continuously monitored. With its flexibility and expandability, Radius VSM can be easily scaled to match each patient’s unique monitoring needs and level of acuity, across the continuum of care, and to accommodate surges in patient volume.

Joe Kiani, Founder and CEO of Masimo, said, “Radius VSM’s unique scalability, versatility, advanced connectivity, and broad range of accurate and automated continuous measurements – all in a wearable device that can be quickly and easily deployed anywhere in the hospital – make it a game-changing tool for clinicians everywhere. Doctors, nurses, and patients in Europe are already experiencing the advantages of Radius VSM and we are excited to share them with U.S. hospitals now too.”

As a modular, wearable device, Radius VSM allows providers to equip any hospital bed with comprehensive monitoring, with the ability to quickly add or remove measurement technologies to match each monitoring scenario and offer more personalized care – without additional bedside equipment, network infrastructure, or any tethered connections. Radius VSM can operate as a self-contained device, with high-quality waveform and parameter trend data shown on its built-in multi-touch LED display, with visual and audible alarms and a built-in rechargeable battery. Or, Radius VSM can connect wirelessly to Masimo bedside monitors like Root® and to the Masimo Hospital Automation™ platform, simplifying clinical workflows by automating patient data transfer to remote monitoring systems like Masimo Patient SafetyNet™ and electronic medical records (EMRs) – enabling its use as a part of a patient surveillance system and ensuring up-to-date physiological data is available to clinicians throughout the hospital. For example, integrating data from Radius VSM into Patient SafetyNet extends its reach across the hospital for clinicians remotely monitoring patients at centralized viewing stations, viewing continuous monitoring data on their Replica®-equipped smartphones, and benefiting from the workflow automation of the Halo ION® patient scoring system – all regardless of where patients are in the hospital, even if they are on the move.

Using a multi-functional pod and a variety of modules and noninvasive sensors designed to prioritize comfort and ergonomics, Radius VSM offers the following measurement technologies:

• Clinically proven Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, including oxygen saturation (SpO₂), pulse rate (PR), perfusion index (Pi), pleth variability index (PVi^®), and plethysmographic respiration rate (RRp^®).
• Multiple respiration rate measurements, including measurement from the pleth, from the sound of breathing, and from impedance.
• Measure-on-inflation noninvasive blood pressure (NIBP), featuring single-patient-use cuffs and automatic intervals (which reduces the need for periodic manual clinician measurement).
• Continuous skin temperature measurements with notifications when clinician-specified temperature thresholds are breached.
• Patient orientation, position, and activity monitoring, alerting clinicians to unsupervised patient movement and possible patient falls, as well as preventable pressure injuries.
• ECG: continuous 6-lead monitoring (I, II, III, aVR, aVL, and aVF) with heart rate, respiration rate, and lethal arrhythmia detection, using single patient use easy-to-apply pre-connected 3-electrode leadwire.
• rainbow Acoustic Monitoring^®, which uses an adhesive sensor to detect the acoustic signals produced by airflow in the upper airway and convert these patterns into respiration rate, also visualized as a waveform.

Peter Pronovost, MD, PhD, FCCM, Chief Quality and Clinical Transformation Officer at University Hospitals, Ohio, and Clinical Professor of Anesthesiology and Perioperative Medicine at Case Western Reserve School of Medicine, said, “Radius VSM represents another radical transformation of care by Masimo, allowing clinicians to monitor based on patient acuity, not their location. With this new technology, not only can every bed have pulse oximetry monitoring, but if patient acuity increases, we can also easily scale up monitoring, even including ECG, without having to add new hardware or hardwire anything. With the staff shortages in hospitals and the high volume of patients, clinicians need the flexibility to put patients in any bed and ensure that that bed has the capability to monitor each patient appropriately. With Radius VSM, we will have enormous flexibility to manage patient risk across a hospital or, in our case, an entire health system: we can tailor what gets monitored to meet each patient’s need, for truly personalized monitoring. And from a safety perspective, by allowing us to monitor patients based on their individual acuity and needs, linked to clinical protocols, we can significantly drive down the risk of possible harm in the hospital.”

Joan Carles Rueda, Deputy Director of Medical Technology at FGS Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, where Radius VSM is already in use, said, “Radius VSM is a reliable solution that combines the advantages of a comprehensive monitoring platform with the autonomy of telemetry, giving the patient the safety and freedom to make their hospital stay more humanized. From a technical perspective, we had no doubt about the reliability of the solution as we have been working with Masimo for many years now. They provided the resources to ensure the proper operation of the technology, even evaluating our wireless network, and it has been working smoothly since the installation. We see the device design as an easy to maintain technology as it all is modular and plug and play.”

Thomas Callahan, MD, Principal Investigator and Director of the Inpatient Hospital Service for Cardiac Electrophysiology and Pacing, Cleveland Clinic, commented, “We are excited to have gained early experience with this next generation inpatient monitoring system at our center as part of the investigational study. What helps differentiate this technology from existing systems is high fidelity continuous ECG monitoring in a compact modular configuration and integration with high precision optical, electrical, and acoustic sensors for blood pressure, respiratory rate, pulse oximetry, and motion.” Business Wire