Masimo Secures FDA 510(k) Clearance for Radius VSM™

Tuesday, June 06, 2023

Masimo, a company listed on NASDAQ as MASI, has recently received FDA 510(k) clearance for its patient-worn vital signs monitor called Radius VSM™. This wearable device is designed on a modular platform and allows clinicians to continuously monitor various physiological measurements, including Masimo SET® pulse oximetry, noninvasive blood pressure, temperature, respiration rate, and electrocardiography (ECG). Radius VSM combines the accuracy and reliability of larger bedside monitors with the comfort and freedom of a wearable device, enabling patients to move and be continuously monitored. Its flexibility and scalability make it suitable for meeting individual patient monitoring needs and acuity levels across different care settings, including managing surges in patient volume.

Joe Kiani, the Founder and CEO of Masimo, highlighted the game-changing potential of Radius VSM, emphasizing its unique scalability, versatility, advanced connectivity, and wide range of accurate and automated continuous measurements. The device has already been providing advantages to doctors, nurses, and patients in Europe, and the company is excited to introduce these benefits to hospitals in the United States.

Radius VSM is a modular and wearable device that allows healthcare providers to equip any hospital bed with comprehensive monitoring capabilities. It offers the flexibility to add or remove measurement technologies as per specific monitoring scenarios, providing personalized care without the need for additional equipment, network infrastructure, or tethered connections. The device can function as a standalone unit, displaying waveform and parameter trend data on its built-in multi-touch LED display, with visual and audible alarms and a rechargeable battery. Alternatively, it can wirelessly connect to Masimo bedside monitors such as Root® and the Masimo Hospital Automation™ platform, streamlining clinical workflows by automating patient data transfer to remote monitoring systems like Masimo Patient SafetyNet™ and electronic medical records (EMRs). This integration enables Radius VSM to be used as part of a patient surveillance system, ensuring clinicians have access to real-time physiological data throughout the hospital. The integration also allows clinicians to remotely monitor patients and view continuous monitoring data on their smartphones equipped with the Replica® system, benefiting from the workflow automation of the Halo ION® patient scoring system.

Radius VSM incorporates various measurement technologies, including Masimo SET® pulse oximetry, multiple respiration rate measurements, noninvasive blood pressure (NIBP) measured during inflation, continuous skin temperature measurements, patient orientation and activity monitoring, ECG with continuous 6-lead monitoring, and rainbow Acoustic Monitoring® for detecting respiration rate. These technologies prioritize patient comfort, ease of use, and accuracy.

Medical professionals have expressed their excitement about Radius VSM, highlighting its potential to transform patient care and improve safety. They appreciate the device's ability to monitor patients based on their acuity, eliminating the need for fixed monitoring equipment and providing flexibility in bed placement. Radius VSM enables personalized monitoring based on individual patient needs, reducing the risk of harm in the hospital environment.

Overall, Radius VSM has received positive feedback from healthcare providers who have experienced its benefits, and it is expected to have a significant impact on patient monitoring and care delivery.


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