Masimo announces FDA clearance of radius PPG™, the first tetherless SET® Pulse Oximetry sensor solution

Masimo announced FDA 510(k) clearance of radius PPG, a tetherless sensor solution powered by Masimo SET® that represents a significant breakthrough in patient monitoring. Radius PPG eliminates the need for a cabled connection to a pulse oximetry monitor, allowing patients to move freely and comfortably while still being continuously monitored reliably and accurately.

Via wireless connection, measurements are displayed on Masimo host devices or third-party multi-parameter monitors with integrated Masimo technology, making Radius PPG immediately available for approximately two million monitors around the world. Coupled with the proven benefits of Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, Radius PPG is suited for use anywhere patients can benefit from mobility.

Radius PPG gives patients freedom of movement without interrupting continuous monitoring. Wireless connection to a host device is simple to establish and each Radius PPG can easily pair with multiple devices (maintaining connection to any one device at a time), simplifying transfers between care areas. Radius PPG works with its integrated battery for about and stores up to (96 hours) of patient data; in the event of wireless interruption, Radius PPG provides seamless retransmission once the connection is restored. Automated by Masimo’s connectivity solutions, patient data can be used for remote clinician notifications of changes in patient condition and automatically transferred to the patient’s EMR.

Studies have shown that patient mobility is a key factor in more rapid patient recovery. In addition, the removal of cables has been shown to contribute to greater patient comfort, convenience, and patient satisfaction compared to tethered patient monitoring. Radius PPG allows patients to move throughout the hospital room, to the bathroom, and to other care areas without the need for physical disconnection and reconnection. In places like the neonatal ICU, care providers and parents can hold infants without interrupting monitoring or risking an uncomfortable tug on the patient. Radius PPG not only offers patients improved comfort and convenience but improves clinician workflows.

Radius PPG harnesses the power of clinically proven Masimo SET® technology to provide accurate measurement even while patients move. Over 100 independent and objective studies have shown that SET® outperforms other pulse oximetry technologies during conditions of motion and low perfusion. When used in conjunction with Patient SafetyNet™, continuous monitoring using SET® in post-surgical wards has been shown to reduce rapid response team activations and transfers back to the ICU. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity (ROP) in neonates and improve critical congenital heart disease (CCHD) screening in newborns. Masimo SET® is estimated to be used on more than 100 million patients in hospitals and other healthcare settings around the world, and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S. News and World Report Best Hospitals Honor Roll.

Joe Kiani, Founder and CEO of Masimo, 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.”