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masimo corp (3M4) Details

Masimo Corporation, a medical technology company, develops, manufactures, and markets various noninvasive patient monitoring products worldwide. The company offers Masimo Signal Extraction Technology (SET), which provides the capabilities of measure-through motion and low perfusion pulse oximetry to address the primary limitations of conventional pulse oximetry; and Masimo rainbow SET products that monitor multiple blood measurements, including oxygen content, carboxyhemoglobin, methemoglobin, hemoglobin, pleth variability index, respiration rate, Halo Index, and In Vivo Adjustment. It develops, manufactures, and markets a family of patient monitoring solutions comprising monitors, circuit boards, sensors, and cables; Root, a patient monitoring and connectivity platform; Masimo Patient SafetyNet, a remote monitoring and clinician notification solution; and various software products. The company also provides line filters, cannulas, and mainstream adapters; and wafer epitaxy, foundry, and device fabrication services to biomedical, telecommunications, consumer products, and other markets, as well as develops and manufactures ultra-compact mainstream and sidestream capnography, and gas monitoring technologies. Masimo Corporation sells its products to hospitals, emergency medical response organizations, physician offices, veterinarians, long term care facilities, consumers, and alternate care market through its direct sales force and distributors, as well as to original equipment manufacturer partners. The company was founded in 1989 and is headquartered in Irvine, California.

3,139 Employees
Last Reported Date: 02/14/14
Founded in 1989

masimo corp (3M4) Top Compensated Officers

Founder, Chairman and Chief Executive Officer
Total Annual Compensation: $712.5K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $334.4K
President of Worldwide Oem Business & Corpora...
Total Annual Compensation: $335.7K
President of Worldwide Sales & Marketing and ...
Total Annual Compensation: $332.4K
Chief Information Officer
Total Annual Compensation: $329.2K
Compensation as of Fiscal Year 2013.

masimo corp (3M4) Key Developments

Yale-New Haven Hospital selects Masimo's Pulse Oximetry

Masimo Corporation has announced that Yale-New Haven Hospital has selected its Masimo SET pulse oximetry. Yale-New Haven Hospital using Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, clinically shown to virtually eliminate false alarms and help clinicians detect life-threatening events.

Masimo Corporation Receives Warning Letter from U.S. Food and Drug Administration

On August 14, 2014, Masimo Corporation received a warning letter from the U.S. Food and Drug Administration (FDA) regarding compliance with current Good Manufacturing Practices at Masimo's Irvine, California manufacturing facility. The Warning Letter follows an FDA inspection that concluded in October 2013. As previously disclosed, at the conclusion of that inspection, the FDA issued Masimo a Form 483 Inspectional Observations (the Form 483). Masimo responded to the Form 483 and provided information to the FDA in October and December 2013. The Warning Letter does not identify any new observations that were not included in the Form 483. Masimo takes the matters identified in the Warning Letter seriously and is in the process of evaluating what corrective actions, and associated costs, may be required to address the matters raised in the Warning Letter. Masimo is also in the process of preparing a response to the Warning Letter and intends to respond fully to the issues raised by the FDA within 15 business days as requested by the FDA and to work expeditiously to address those issues. The Warning Letter does not restrict the manufacture, production or shipment of any of Masimo's devices, nor require the withdrawal of any product from the marketplace. Masimo will diligently work with the FDA to resolve the issues raised in the Warning Letter. However, failure to promptly address the issues raised in the Warning Letter to the FDA's satisfaction or to comply with U.S. medical device regulatory requirements in general could result in regulatory action being initiated by the FDA. These actions could include, among other things, product seizures, injunctions and civil money penalties.

Masimo Corporation Announces New Study of Masimo Noninvasive and Continuous Hemoglobin (SpHb(R)) Monitoring Evaluates Trending and Accuracy in Pediatric Patients

Masimo Corporation announced that in a new study published in the journal Anesthesia and Analgesia, Masimo's noninvasive and continuous hemoglobin (SpHb(R)) technology showed a positive correlation for trending when compared with invasive lab measurements in pediatric patients undergoing surgeries with potential for substantial blood loss. Researchers collected 158 SpHb and laboratory hemoglobin (Hb) data pairs and 105 delta pairs (SpHb and Hb) from 46 patients aged 2 months to 17 years with Hb ranging from 16.7 g/dL to 7.9 g/dL. Patient selection was limited to those undergoing surgical procedures associated with substantial blood loss, such as cardiac surgery, liver/small bowel transplantation, and multilevel spine surgeries. The primary goal of the study was to compare the magnitude and direction of change (trending) of SpHb versus that of the reference device. The authors found that the sensitivity of SpHb to correctly detect directional changes in Hb was 95% (95% CI = 0.83-0.99). The researchers calculated SpHb's correlation coefficient at r=0.76. Additionally, 95% of the individual data points were either in the upper right or in the lower left quadrant of the trending plots, showing changes in SpHb and Hb in the same direction. Additionally, researchers found point accuracy bias and standard deviation of 0.4 +/- 1.3 g/dL and with Invivo Adjustment, 0.1 +/- 1.2 g/dL. The limits of agreement were -2.0 to 3.2 g/dL before Invivo Adjustment and -2.4 to 2.2 g/dL after Invivo Adjustment (P value = 0.04). Invivo Adjustment, a feature currently available in select European and other non-U.S. markets, allows clinicians to adjust the SpHb measurement to that of an initial blood sample analyzed with the clinician's invasive reference hemoglobin analyzer. This feature helps account for reference invasive instrument and individual patient variation.


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