Masimo has received FDA 510(k) clearance for its Radius PPG, a tetherless sensor solution powered by Masimo SET that represents a major breakthrough in patient monitoring.

17May - Masimo

Image: Masimo has received FDA 510(k) clearance for its Radius PPG, a tetherless sensor solution. Photo: Courtesy of Masimo.

Masimo has designed its Radius PPG to eliminate the need for a cabled connection to a pulse oximetry monitor and allow patients to move freely and comfortably while still being continuously monitored accurately.

Radius PPG enables Masimo host devices or third-party multi-parameter monitors with integrated Masimo technology to display measurements through a wireless connection.

The company said that the Radius PPG is coupled with the proven benefits of Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, and provides patients with freedom of movement without interrupting continuous monitoring.

Radius PPG is capable of working for approximately four days with its integrated battery and stores up to four days (96 hours) of patient data. In case of interruption in wireless network, the device offers unbroken retransmission once the connection is restored.

The patient data transmitted can be used for remote clinician notifications of changes in patient condition using Masimo’s automated connectivity solutions and automatically transferred to the patient’s EMR.

Masimo founder and CEO Joe Kiani said: “We are excited to announce the Radius PPG tetherless, wearable SET pulse oximetry sensor solution. Accurate, high-quality monitoring data can now travel from an ambulating patient to a variety of monitoring platforms, allowing a patient’s physiological status to be continuously monitored when it’s needed most.”

Studies have shown that patient mobility plays key factor in patient recovery and removal of cables has been shown to result in greater patient comfort, convenience, and patient satisfaction compared to tethered patient monitoring.

In addition, Radius PPG not only provides patients with improved comfort and convenience but improves clinician workflows.

The company said that its solution harnesses the power of clinically proven Masimo SET technology, where more than 100 independent and objective studies have shown that SET outperforms other pulse oximetry technologies during conditions of motion and low perfusion.