Masimo Pronto-7(TM) Receives Japanese and Canadian Regulatory Clearances
IRVINE, Calif., Aug. 29, 2011 /PRNewswire/ — Masimo (NASDAQ: MASI) today announced the Japanese Ministry of Health Labor & Welfare (MHLW) and Health Canada regulatory clearances of Masimo Pronto-7(TM)– enabling clinicians throughout Japan and Canada to quickly and conveniently measure total hemoglobin (SpHbÃ‚®), SpO2, perfusion index, and pulse rate without removing a drop of blood.
Hemoglobin is one of the most commonly ordered tests in both the hospital and pre-hospital settings because it is critical to assessing blood loss following trauma, during surgery, and during hospital stay, as well as a patient’s need for a blood transfusion. However, traditional lab testing requires a painful needle stick for the patient, time-consuming blood draws for the clinician, and typically provides delayed results. Masimo SpHb provides immediate real-time hemoglobin results that enable clinicians to more rapidly assess patients and detect and treat internal bleeding and low hemoglobin conditions earlier. And, although Masimo noninvasive and continuous total hemoglobin (SpHb) monitoring–commercially available in both Japan and Canada for over a year–is the preferred technology for hospitals and inpatient care centers, access to quick and easy spot-check hemoglobin measurements are valuable for a variety of healthcare assessment applications, including physician offices, outpatient care centers, and pre-hospital emergency settings.
Pronto-7 Makes Noninvasive Hemoglobin Testing a Reality in Japan and Canada
Japanese and Canadian regulatory clearances for the palm-sized, handheld Pronto-7 and noninvasive finger sensors make it possible for clinicians to take the pain and wait out of traditional hemoglobin blood testing. The Pronto-7 offers a breakthrough solution for measuring total hemoglobin, SpO2, perfusion index, and pulse rate in less than one minute without the needles, time-consuming laboratory analysis, risk of blood contamination, hazardous medical waste, and patient discomfort associated with traditional blood tests. With dimensions of just 13 cm x 7.2 cm x 2.5 cm (5.1″ x 2.8″ x 1″) and weight of 296 grams (10.5 ounces), the palm-sized Pronto-7 puts the power of noninvasive hemoglobin spot-check testing, along with SpO2, perfusion index, and pulse rate into any clinician’s hands in various clinical settings–including physician offices, hospitals, clinics, and on the scene of medical emergencies.
In addition to Normal Mode, Pronto-7 offers Max Sensitivity Mode that allows measurement over a broader range of patients and three noninvasive sensor sizes to accommodate the range of finger diameters. Each sensor is color-coded to make size identification easy (Small-Yellow, Medium-Red, and Large-White) and optimized to improve performance in low ambient temperatures. And, because of the device’s embedded 802.11 b/g and Bluetooth communication capability, wireless printing or emailing of test results is enabled with future upgrades that will allow for wireless transmission to electronic health record (EHR) systems.
Prior to the introduction of the Pronto-7, Masimo received U.S. FDA 510(k) and CE Mark clearance and first introduced the ability to noninvasively and continuously measure total hemoglobin (SpHb) in 2008 using its Radical-7 bedside Pulse CO-Oximeter. In 2009, Masimo launched ProntoÃ‚®–its first handheld noninvasive spot-check device for total hemoglobin, SpO2, perfusion index, and pulse rate measurements. And in 2010, Masimo established Medicare reimbursement for transcutaneous hemoglobin measurement in the United States.
Masimo Founder and CEO, Joe Kiani, stated: “The potential impact of noninvasive total hemoglobin, SpO2, perfusion index, and pulse rate spot-check measurement offers healthcare providers in Japan and Canada the opportunity to transform the way and amount of time it takes to deliver the right care, at the right time to patients. We believe that the Pronto-7 will help clinicians to better assess more patients and make better clinical decisions based on the availability of quick and noninvasive hemoglobin measurement.”
* Masimo Pronto-7 is pending FDA 510(k) clearance in the U.S.
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 SETÃ‚®, 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 SETÃ‚® Pulse CO-Oximetry(TM) technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHbÃ‚®), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCOÃ‚®), methemoglobin (SpMetÃ‚®), and Pleth Variability Index (PVIÃ‚®), in addition to SpO2, pulse rate, and perfusion index (PI). 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 noninvasive and continuous monitoring of acoustic respiration rate (RRa(TM)). Masimo’s rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLineÃ‚®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can be also 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 ApplicationsÃ‚®.” 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 of the repeatability of clinical results obtained using the enhanced Masimo Pronto-7 and noninvasive sensor sizes, risks related to our belief that the Pronto-7 enables quick and easy noninvasive spot-checking of hemoglobin (SpHbÃ‚®), SpO2, pulse rate, and perfusion index at the point-of-care 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 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.
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