FDA Clears Masimo’s 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 four days and stores up to four days (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.^1,2 In addition, the removal of cables has been shown to contribute to greater patient comfort, convenience, and patient satisfaction compared to tethered patient monitoring^.3 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.⁴ 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.^5-7 Masimo SET has also been shown to help clinicians reduce severe retinopathy of prematurity (ROP) in neonates⁸ and improve critical congenital heart disease (CCHD) screening in newborns.⁹ Today, Masimo SET is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,¹⁰ 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.¹¹
 
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.”
 
References
¹ Needham D et al. Archives of Physical Medicine and Rehabilitation. Vol 91, Issue 4, PP 536–542, April 2010.
² Ronnenbaum J et al. J Acute Care Phys Ther. 2012;3(2):204-210.
³ Fensli R et al. J Med Syst (2010) 34: 767. https://doi.org/10.1007/s10916-009-9291-8.
⁴ Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
⁵ Taenzer AH et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
⁶ Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
⁷ McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
⁸ Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
⁹ de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
¹⁰ Estimate: Masimo data on file.
¹¹ http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.