Masimo wins FDA clearance for wearable vital sign monitor

June 5, 2023 By Sean Whooley

Radius VSM enables physicians to monitor a range of physiological measurements. That includes Masimo SET pulse oximetry, noninvasive blood pressure, temperature, respiration rate and ECG.

Masimo said its monitor combines the reliability and accuracy of larger bedside monitors with the comfort and freedom of wearable devices. It enables ambulation and movement while ensuring patients remain continuously monitored. The company said it has the scalability to match each patient's unique monitoring needs and level of acuity.

Radius VSM, a modular, wearable device, enables providers to equip any hospital bed with comprehensive monitoring. They can quickly add or remove measurement technologies to match each monitoring scenario, leading to more personalized care.

It can operate as a self-contained device or connect wirelessly to Masimo bedside monitors. That includes Root and the Masimo Hospital Automation platform, simplifying workflows by automating patient data transfer to remote systems.

The system uses a multi-functional pod and a variety of modules and noninvasive sensors. It provides measurements for pulse oximetry, respiration rate, blood pressure and skin temperature. Radius VSM alerts clinicians to unsupervised patient movement and possible patient falls, plus preventable pressure injuries.

Masimo designed the ECG capabilities to use continuous six-lead monitoring with heart rate, respiration rate and lethal arrhythmia detection. It utilizes a single-patient-use, easy-to-apply, pre-connected three-electrode leadwire. The system's rainbow acoustic monitoring capability also detects acoustic signals produced by airflow in the upper airway.

"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," said Joe Kiani, Masimo founder and CEO. "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."

Filed Under: 510(k), Business/Financial News, Diagnostics, Food & Drug Administration (FDA), Health Technology, Hospital Care, Patient Monitoring, Regulatory/Compliance Tagged With: FDA, Masimo