Masimo Announces FDA 510(k) Clearance Of Radius-7 – First Rainbow SET Noninvasive Wearable, Wireless Monitor For Root

Continuous, Untethered Monitoring of Oxygenation and Respiration Designed to Mobilize Patients

Masimo recently announced FDA 510(k) clearance of Radius-7 for the Root patient monitoring and connectivity platform, the first and only wearable, wireless monitor with Masimo's breakthrough rainbow SET technology, offering patients continuous monitoring with freedom of movement.

With rainbow SET noninvasive measurements, Radius-7 with Root can alert clinicians – at the bedside or remotely, through the Masimo Patient SafetyNet remote monitoring and notification system – of critical changes in a patient's oxygen saturation and pulse rate – even during states of motion and low perfusion – as well as respiration through acoustic respiration rate (RRa). Lightweight at only 0.34 lbs. (155g), the Radius-7 attaches to the patient's arm or can be placed alongside the patient in their bed, allowing untethered monitoring while they are in bed or out. With no need to disconnect and reconnect the cable to get out of bed, the Radius-7 reduces the need for nursing assistance. And the Radius-7's wireless communication functionality – either short-range via Bluetooth back to Root or with upgradeable WiFi for long-range communication – ensures the patient can be continuously monitored and connected to caregivers wherever they are in the hospital.

Studies have shown that patient mobility is a key factor in more rapid patient recovery.¹ Radius-7 allows clinicians to continuously monitor their patients when they are mobile.

¹ Needham D, Korupolu R, Zanni J, Pradhan P, Colantuoni E, Palmer J, Brower R, Fan E. "Early Physical Medicine and Rehabilitation for Patients With Acute Respiratory Failure: A Quality Improvement Project." Archives of Physical Medicine and Rehabilitation Vol 91, Issue 4, PP 536–542, April 2010.

About Masimo
Masimo is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET, which virtually eliminated false alarms and increased pulse oximetry's ability to help clinicians detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb), oxygen content (SpOC), carboxyhemoglobin (SpCO), methemoglobin (SpMet), PVI, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. In 2008, Masimo introduced Patient SafetyNet, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic Monitoring, the first-ever commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa). Masimo SET and Masimo rainbow technologies also can be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care � by Taking Noninvasive Monitoring to New Sites and Applications." For more information, visit www.masimo.com.