Masimo Radical-7(R) and Rad-57(R) Pulse CO-Oximeters(TM) Awarded Airworthiness Release Certification by the United States Army
IRVINE, Calif., Sept. 3 /PRNewswire-FirstCall/ — Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, today announced that its Radical-7 and Rad-57 Pulse CO-Oximeters have achieved Airworthiness Release (AWR) Certification from the United States Army. AWR certification is a fundamental milestone that allows the U.S. military to use Masimo’s multi-function, advanced noninvasive patient monitoring devices during flight operations aboard rotary aircraft.
The U.S. Army Aeromedical Research Laboratory (USAARL) completed extensive aeromedical testing and evaluation on the Radical-7 and Rad-57–including electromagnetic interference and compatibility, environmental, vibration/motion, and human factors testing–to certify that both devices meet stringent requirements to operate onboard U.S. military aircraft in flight. Meeting the Army’s airworthiness testing requirements and standards affirms the durability, reliability and superior performance of both the Radical-7 and Rad-57, which are designed to excel in a wide range of demanding environments, including those faced by emergency medical services, fire, law enforcement, military field medical operations and medevac units.
Joe E. Kiani, Founder and CEO of Masimo, stated, “We are proud of our long-standing presence in military hospitals. Now, with the Radical-7 and Rad-57 both receiving airworthiness certification, U.S. troops can benefit from definitive, lifesaving physiological monitoring from the moment they need it on the ground and during transport to a medical center. Masimo is committed to supporting the military through the entire care continuum, from the battlefield to the bedside.”
The Masimo Radical-7 Pulse CO-Oximeter features first-ever noninvasive and continuous hemoglobin (SpHb((TM))) monitoring technology, which may allow combat medics to quickly and easily detect and assess the severity of internal bleeding and provide the most appropriate frontline trauma care on the battlefield. During surgery, the Radical-7 may help guide more effective transfusions and enable better blood management strategies. Radical-7 also noninvasively and continuously measures oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO((R))), methemoglobin (SpMet((R))), PVI(TM) for fluid responsiveness, oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate to quickly detect and treat potentially life-threatening conditions earlier. The Masimo Rad-57 portable, handheld Pulse CO-Oximeter accurately and noninvasively measures carboxyhemoglobin (SpCO) and methemoglobin (SpMet) levels in the blood in seconds, along with SpO2 and pulse rate to facilitate rapid, reliable treatment decisions in military settings where carbon monoxide poisoning or methemoglobinemia may be encountered.
Masimo (NASDAQ: MASI) develops innovative 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 detect life-threatening events. More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb((TM))), oxygen content (SpOC((TM))), carboxyhemoglobin (SpCO((R))), methemoglobin (SpMet((R))), and PVI((TM)), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), allowing early detection and treatment of potentially life-threatening conditions. Founded in 1989, Masimo has the mission of “Improving Patient Outcomes 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.
Forward Looking Statements
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 repeatability of the performance and results for the Radical-7 and Rad-57 Pulse CO-Oximeters during laboratory and flight operations, 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.
Contact: Dana Banks Masimo Corporation 949-297-7348
Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57, Rad-9, Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.