Masimo Announces FDA 510(k) Clearance of Radius VSM™

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Masimo Radius VSM

IRVINE, Calif.– Masimo (NASDAQ: MASI) today 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.