Masimo gets FDA 510(k) clearance for Radius-7 with rainbow technology

29 June 2016 (Last Updated June 29th, 2016 18:30)

US-based medical technology company Masimo has secured the US Food and Drug Administration (FDA) 510(k) clearance for Radius-7 with rainbow technology.

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US-based medical technology company Masimo has secured US Food and Drug Administration (FDA) 510(k) clearance for Radius-7 with rainbow technology.

The Radius-7 is a wearable, tetherless, noninvasive rainbow monitor, which integrates to the Root patient monitoring and connectivity platform.

The device offers a continuous monitoring of the patient's hemoglobin concentration (SPHB) in a non-invasive way.

An SPHB enables clinicians to make an informed and a prompt clinical decision while helping them in offering timely blood transfusions and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.

Masimo founder and CEO Joe Kiani said: "Never before could patients be monitored for such key parameters as continuous SPHB, which can help clinicians make more timely and informed blood management decisions, while patients are fully mobile.

"Previous wearable patient monitors were hampered by a limited range of measurements and false alarms due to motion.

"Root with Radius-7 with rainbow SET, coupled with Patient SafetyNet for mobile clinician notification, is now an even more versatile and powerful monitoring system, all while promoting freedom of patient movement and quicker recovery times."

The usage of the device does not hinder patient's mobility which is considered important to facilitate a rapid recovery.

"The usage of the device does not hinder patient's mobility which is considered important to facilitate a rapid recovery."

While monitoring an ambulating patient, the Radius-7 communicates to Masimo Patient SafetyNet via Root installed at the bedside to alert clinicians of critical changes in oxygen saturation, pulse rate, respiration, and hemoglobin, among other parameters.

The lightweight monitor attaches to the arm and monitors whether a patient is in or out of bed.

It eliminates the need for a nurse or the need to disconnect or reconnect to a bedside monitor.

Each Radius-7 is installed with two hot-swappable rechargeable battery modules with a battery life of 12 hours.


Image: Masimo Root with Radius-7 with rainbow. Photo: courtesy of Masimo.