Continuous, Untethered Monitoring of Oxygenation and Respiration Designed to Mobilize Patients
IRVINE, CA -- (Marketwired) -- Masimo (NASDAQ: MASI) today announced FDA 510(k) clearance of Radius-7(tm) 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(tm) 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
Masimo (NASDAQ: MASI) 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(tm) technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC(tm)), 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(tm), 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(tm), the first-ever commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa(tm)). 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®." Additional information about Masimo and its products may be found at www.masimo.com.
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our assumptions that Radius-7(tm) enables continuous monitoring with unprecedented patient ambulation and independence; reduces the need for nursing assistance; and allows for greater continuous monitoring for improved patient safety for all patients; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these forward-looking statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation