Masimo Receives FDA Clearance for Pronto-7 Making the Revolutionary Palm-sized Device for Noninvasive Hemoglobin Spot-Check Testing Available to U.S. Healthcare Providers
IRVINE, Calif., June 28 Masimo (Nasdaq: MASI), the inventor of Masimo Rainbow Pulse CO-Oximetry(TM), Masimo Rainbow Acoustic Monitoring(TM), and Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry, today announced FDA 510(k) clearance for the Pronto-7(TM)--a new handheld device designed for quick and easy noninvasive hemoglobin (SpHb®) spot-check testing, along with SpO2, pulse rate, and perfusion index, in virtually any environment.
Masimo Founder and CEO, Joe Kiani, stated: "We are happy that in addition to the CE Marking we now have FDA clearance for Pronto-7, allowing U.S. clinicians and patients to also benefit from the latest technology for noninvasive hemoglobin spot-check testing."
Dr. Anunciacion Andro, a busy primary care physician in Hesperia, California, says needle-less, pain-free hemoglobin testing has big patient care benefits: "The ability to get noninvasive hemoglobin spot-check results has been a great benefit to my patients--who are happy to not be stuck with a needle."
Dr. Aditya Chopra, a private practice internist in Annapolis, MD, confirmed the value of fast, point-of-care spot-check testing in his practice, saying: "Noninvasive hemoglobin spot-check testing has increased the efficiency of my practice by reducing the time to take blood, send it to the lab, and call patients back with their results."
A low hemoglobin level is called anemia, a pervasive blood disorder that, according to the World Health Organization (WHO), affects 1.6 billion people worldwide and causes one million deaths a year. A top-ten risk factor contributing to the global burden of disease, anemia results in lost cognitive function and productivity that is estimated to cost $50 billion annually in gross domestic product (GDP) losses worldwide. Chronic anemia is characterized by consistently low hemoglobin levels that can be the result of a diet deficiency or illness such as cancer. Acute anemia is a sudden drop in hemoglobin levels that can result from internal or external bleeding due to surgery or trauma.
According to Aryeh Shander, M.D., President-Elect of the Society for the Advancement of Blood Management (SABM) and the Executive Medical Director for The Institute for Patient Blood Management & Bloodless Medicine and Surgery at Englewood Hospital and Medical Center in Englewood, New Jersey, "Noninvasive hemoglobin testing at the point-of-care offers a giant leap forward in our ability to tackle the global burden of anemia. Although it is a common blood disorder, it is grossly under-tested and under-diagnosed. And, if left untreated, anemia has a variety of serious health consequences and complications. The beauty of immediate, noninvasive hemoglobin testing is that it will allow more patients to be assessed, so their physician can determine additional test options and initiate potentially lifesaving treatment."
Hemoglobin is one of the most commonly ordered tests in both hospital and non-hospital settings because it is critical to assessing anemia and blood loss. However, traditional lab testing requires a painful needle stick for the patient, time-consuming blood draws for the clinician, and typically provides delayed results. The palm-sized Pronto-7--with dimensions of just 5.1" x 2.8" x 1" and weight of 10.5 ounces-- represents a breakthrough solution for measuring hemoglobin in less than one minute. It puts the power of noninvasive hemoglobin spot-check testing into any clinician's hands in almost any environment--without the needles, time-consuming laboratory analysis, risk of blood contamination, hazardous medical waste, and patient discomfort associated with traditional blood tests.
Pronto-7 features embedded 802.11 b/g and Bluetooth communication capabilities that make wireless printing and emailing of test results quick and easy and future capabilities enabling wireless transmission to electronic health record (EHR) systems are planned. It is also the first Masimo device to feature Rainbow 4D(TM)--designed for fast and accurate spot-check SpHb measurements, along with SpO2 and pulse rate, even in low perfusion conditions.
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 Rainbow Pulse CO-Oximetry(TM), allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2009, Masimo introduced Rainbow Acoustic Monitoring(TM), the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa(TM)). Masimo's Rainbow platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. 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 assumption that Masimo noninvasive and continuous total hemoglobin (SpHb) will provide faster, easier and safer means for measuring total hemoglobin over alternative hemoglobin measurement methods, risks related to our belief that Masimo Pronto-7 enables clinicians to simply, quickly, and painlessly assess their patients' hemoglobin status to uncover hidden health dangers and potentially life-threatening conditions, risks related to our assumptions that the availability of Pronto-7 will lead to additional device sales, 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 Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, RRa, 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.
Media Contacts: Dana Banks Masimo Corporation (949) 297-7348 email@example.com
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