Masimo Announces FDA 510(k) Clearance for Radius-7® with rainbow® Technology, Including Continuous SpHb®
Radius-7 is the First Wearable, Tetherless, Noninvasive rainbow® Monitor
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SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings – when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. SpHb may thus help clinicians make more timely and informed decisions, and has been shown to help clinicians provide more timely blood transfusions* and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.1,2
For the first time, it is possible to offer patients freedom of movement while providing such important monitoring, and studies have shown that patient mobility is a key factor in more rapid patient recovery.3,4 When monitoring ambulating patients, Radius-7 communicates to Root at the bedside and thereby to Masimo Patient SafetyNet™ to alert clinicians of critical changes in oxygen saturation, pulse rate, respiration, and hemoglobin, among other parameters. Radius-7 is lightweight, weighing only 0.34 lbs, and attaches to the arm, thus allowing untethered monitoring whether a patient is in or out of bed – which also reduces the need for nursing assistance, as there is no need to disconnect from or reconnect to a bedside monitor. Each Radius-7 comes with two “hot-swappable” rechargeable battery modules (one with the patient, one charging), each with a battery life of 12 hours, minimizing monitoring interruption.
“Never before could patients be monitored for such key parameters as
continuous SpHb, which can help clinicians make more timely and informed
blood management decisions, while patients are fully mobile. Previous
wearable patient monitors were hampered by a limited range of
measurements and false alarms due to motion,” said
*Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
@MasimoInnovates | #Masimo
Ehrenfeld JM et al. J Blood Disorders Transf. 2014. 5:9. 2.
Awada WN et al. J Clin Monit Comput. 2015 Feb 4.
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.
Ronnenbaum J, Weir J, Hilsabeck T. Earlier mobilization decreases length of stay in the intensive care unit. J Acute Care Phys Ther. 2012;3(2):204-210.
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
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 include, among others, statements regarding the potential
effectiveness of Masimo’s Radius-7®. 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 belief that Masimo's unique noninvasive measurement
technologies, including Masimo’s Radius-7®, contribute to
positive clinical outcomes and patient safety; risks related to our
belief that Masimo noninvasive medical breakthroughs provide
cost-effective solutions with comparable accuracy and unique advantages,
including: immediate and continuous results that enable earlier
treatment without causing invasive trauma in all patients and in every
clinical situation; as well as other factors discussed in the "Risk
Factors" section of our most recent reports filed with the