Masimo

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Type Public (NASDAQMASI
Industry Medical Technology
Medical Devices
Medical Equipment
Founders Joe E. Kiani
Headquarters Irvine, California, United States
Area served Worldwide
Revenue US $547.2 million [1]
Employees 3,500 (2014)
Website www.masimo.com

Masimo is an Irvine, California-based manufacturer of noninvasive patient monitoring technologies.[2] The company is best known for its pulse oximetry and it sells more pulse oximeters to hospitals than any other company.[3] Masimo was founded in 1989 by electrical engineer Joe Kiani, who was later joined by fellow engineer Mohamed Diab.[4] Masimo invented measure-through motion and low perfusion pulse oximetry, known as Masimo SET (Signal Extraction Technology). Masimo has been recognized for its intellectual property and for being one of the most innovative companies in the medical device industry.[5] The company went public in 2007[6] and is currently traded on the NASDAQ stock exchange under the symbol MASI. In 2011, Forbes named Masimo to its list of top 20 public companies under a billion dollars in revenue, based on earnings growth, sales growth, and return on equity.[7][8] In 2012, Joe Kiani, founder, CEO and Chairman of the Board was named the Ernst & Young National Entrepreneur of the Year - 2012 Life Sciences Award Winner. Kiani was recognized for "revolutionizing the health care industry by taking risks to create and commercialize noninvasive patient monitoring devices, which include an array of sensors that lead to improved accuracy, a reduction in the overall number of false readings, and ultimately, reduced cost of care."[9]

Technology[edit]

Signal Extraction Technology (SET) pulse oximetry[edit]

True and false SpO2 alarm rate of Masimo SET versus 19 competing pulse oximetry technologies.[10]
The Masimo Radical-7 is a pulse oximeter that can also noninvasively measure a patient's hemoglobin and respiration rate.
Masimo SET adhesive sensors monitor oxygenation, pulse rate and special rainbow® sensors allow additional measurement of noninvasive blood constituents.

Pulse oximetry uses two light emitting diodes (LEDs), one red and one infrared, to measure the absorption of light and translates that into the percentage of hemoglobin molecules that are bound with oxygen, which is called arterial oxygen saturation (SpO2). Conventional pulse oximetry assumes that arterial blood is the only blood moving (pulsating) in the measurement site. However, during patient motion, the venous blood also moves, which can cause conventional pulse oximetry to under-read SpO2 levels because it cannot distinguish between the arterial and venous blood.[11][12] SET identifies the venous blood signal (which has a lower oxygen saturation level than arterial blood), isolates it, and uses adaptive filters to cancel the noise and extract the arterial signal in order to report accurate SpO2 and pulse rate. In addition, SET pulse oximetry provides perfusion index (PI) and pleth variability index (PVI). Multiple studies have shown that compared to non-SET pulse oximeters, SET increases the ability to detect life-threatening events and reduces false alarms during challenging conditions.[13][10] Additional studies have also shown the impact of SET on patient outcomes, such as helping clinicians:

  • Decrease retinopathy of prematurity (ROP) in neonates[14][15]
  • Increase detection of critical congenital heart disease (CCHD) in newborns[16]
  • Reduce ventilator weaning time by titrating FiO2 faster and reduce arterial blood gas measurements in the Intensive Care Unit (ICU)[17]
  • Decrease rapid response activations and Intensive Care Unit (ICU) transfers to save lives and costs in post-surgical patients on the medical-surgical floors through earlier identification of patients in distress through low SpO2 and abnormal pulse rate measurements[18][19]
  • Decrease fluid administered during surgery and reduce patient risk[20]

In 2011, the American Academy of Pediatrics and the U.S. Department of Health and Human Services recommended mandatory screening for all newborns, using "motion-tolerant pulse oximeters that report functional oxygen saturation have been validated in low perfusion conditions".[21] To make this recommendation, the CCHD workgroup relied on two independent studies that exclusively used SET pulse oximetry to assess newborns. In 2012, Masimo received FDA 510(k) clearance for devices and sensors with labeling for screening newborns for CCHD. It marked the first time the FDA cleared specific labeling indicating the use of pulse oximeters, in conjunction with a physical examination, to screen newborns for CCHD.[22] In 2012, the National Health Service (NHS) Technology Adoption Centre in the United Kingdom advised hospitals to use Intraoperative Fluid Management Technologies as a way to improve patient outcomes, and included Masimo's PVI among technologies available for helping clinicians manage fluid during surgeries.[23] In 2013, the French Society for Anaesthesia and Intensive Care (SFAR) added PVI to its guidelines for optimal hemodynamic management of surgical patients.[24]

Rainbow Pulse CO-Oximetry[edit]

Rainbow Pulse CO-Oximetry uses more than seven wavelengths of light to continuously and noninvasively measure hemoglobin (SpHb), carboxyhemoglobin (SpCO), and methemoglobin (SpMet), in addition to oxygen saturation (SpO2), pulse rate, perfusion index (PI), and pleth variability index (PVI).[25] A study at Massachusetts General Hospital showed that SpHb monitoring helped clinicians decrease the frequency of patients receiving blood transfusions during surgery from 4.5% to 0.6%.[26] Another study from Cairo University showed that SpHb monitoring helped clinicians reduce blood transfusions in high blood loss surgery by an average of 0.9 units per patient.[27] Emergency department studies have shown that SpCO helps clinicians increase the detection of carbon monoxide (CO) poisoning and decreases the time to treatment compared to invasive methods.[28][29][30] The Pronto-7 device for noninvasive spot checking of hemoglobin, along with SpO2 and pulse rate, has been recognized with a gold Medical Design Excellence Award.[31] The World Health Organization called noninvasive hemoglobin an "innovative medical technology for cost-effectively addressing global health concerns and needs".[32]

In October 2014, Masimo announced CE Mark of Oxygen Reserve Index or ORI, the company’s 11th noninvasive parameter, which provides real-time visibility to oxygenation status. ORI is intended to supplement, not replace, oxygen saturation (SpO2) monitoring and partial pressure of oxygen (PaO2) measurements. ORI can be trended and has optional alarms to notify clinicians of changes in a patient’s oxygen reserve, and may enable proactive interventions to avoid hypoxia and unintended hyperoxia.

Noninvasive Patient Monitoring[edit]

Patient SafetyNet[edit]

Patient SafetyNet is a remote monitoring and notification system designed for patients on medical/surgical care floors.[33] A large study by Dartmouth-Hitchcock Medical Center showed Patient SafetyNet helped clinicians achieve a 65% reduction in distress codes and rescue activations and a 48% decrease in patient transfers to intensive care units (ICU), yielding a savings of 135 Intensive Care Unit (ICU) days annually for an annual opportunity-cost savings of $1.48 million.[34][35] ECRI Institute gave Dartmouth its Health Devices Achievement Award for its use of Patient SafetyNet to prevent "severe patient harm".[36] Masimo has introduced Halo Index in the Patient SafetyNet system, combining multiple physiologic parameters into one number to help clinicians assess overall patient status.[37]

Rainbow acoustic monitoring[edit]

Rainbow acoustic monitoring provides noninvasive and continuous measurement of respiration rate using an adhesive sensor with an integrated acoustic transducer that is applied to the patient's neck.[38][39] Researchers have evaluated acoustic respiration rate (RRa) and found the acceptable accuracy and significantly fewer false alarms than traditional respiration rate monitoring methods, end-tidal carbon dioxide (EtCO2) and impedance pneumography.[40]

SedLine brain function monitoring[edit]

In 2010, Masimo began offering brain function monitoring to measure the effects of anesthesia and sedation by monitoring both sides of the brain's electrical activity (EEG). Studies have shown this results in more individualized titration and improved care.[41]

Capnography and gas monitoring[edit]

In 2012, Masimo began offering ultra-compact mainstream and sidestream capnography as well as multigas analyzers for end-tidal carbon dioxide (CO2), nitric oxide (N2O), oxygen (O2), and anesthetic agents, for use in the operating room, procedural sedation, and in intensive care units (ICU).[42] A multi-center study at Cincinnati Children's Hospital Medical Center, University Medical Center (Tucson, Arizona), and Children's Medical Center (Dallas), found that respiratory rate measured from noninvasive, acoustic monitoring had similar accuracy and precision as nasal capnography, the current standard of care when used in pediatric patients.[43]

Significant Product Releases[edit]

Root is an intuitive patient monitoring and connectivity platform.

Root[edit]

On June 3, 2013, Masimo announced CE Mark of Root, an intuitive patient monitoring and connectivity platform designed to transform patient care from the operating room to the Intensive Care Unit (ICU) to the general floor. On June 30, 2014, Masimo announced FDA 510(k) clearance of Root. Features available in the U.S. include:

O3 regional oximetry[edit]

On January 23, 2014, Masimo announced CE Mark O3 regional oximetry for the Root patient monitoring and connectivity platform. Regional oximetry, also referred to as tissue oximetry and cerebral oximetry, enables the continuous assessment of the oxygenation of the tissue beneath the sensor. O3 helps clinicians detect regional hypoxemia that pulse oximetry alone can miss.

The wearable, wireless Radius-7 offers continuous, noninvasive patient monitoring with comfort and freedom of movement.

Radius-7[edit]

On December 1, 2014, Masimo announced FDA 510(k) clearance of Radius-7 for the Root patient monitoring and connectivity platform, the first and only wearable, wireless monitor with Masimo’s rainbow SET technology, enabling early identification of clinical deterioration while offering patients continuous monitoring with freedom of movement. Radius-7 attaches to the patient’s arm or can be placed alongside the patient in their bed, allowing untethered monitoring. Studies have shown that patient mobility is a key factor in more rapid patient recovery.[44]

Eve[edit]

On October 10, 2014, Masimo announced CE Mark for Eve Newborn Screening Software Application for Radical-7 Pulse CO-Oximeters. Eve is designed to help clinicians screen newborns for critical congenital heart disease (CCHD). Newborn screening protocols may present challenges, such as longer-than-necessary monitoring times, misapplication of sensors, calculation errors, and confusion interpreting results. Eve automates the screening steps with animated instruction, including sensor application, measurement selection, and screening result determination.

iSpO2 Pulse Oximeter for smart phones and tablets[edit]

iSpO2 is the first commercially available pulse oximeter for iOS (iPhone, iPad & iPod touch) and the Android operating system.[45] Available on Amazon, iSpO2 uses the same standard-of-care pulse oximetry technology found in Masimo’s line of pulse oximeters and Pulse CO-Oximeters used in hospitals around the world. At the 2013 EMS Today Conference & Exposition, the iSpO2 pulse oximeter was awarded the Hot Product Award.[46]

Supported Causes[edit]

Clinton Global Initiative[edit]

In 2012, Masimo embarked on its first Commitment to Action with the Clinton Global Initiative (CGI) to solve the global problem of maternal mortality and anemia. The $1 million, two-year project initially focuses on five villages in Liberia and Uganda – two countries where the epidemics of maternal mortality and anemia are among the worst.[47]

Patient Safety Movement Foundation[edit]

In 2013, Masimo founder, Chairman and CEO Joe Kiani, created the nonprofit Patient Safety Movement Foundation with a mission to eliminate the more than 200,000[48] preventable patient deaths that occur in U.S. hospitals each year. The foundation holds annual Patient Safety, Science & Technology Summits, featuring leaders from healthcare, industry, and government; former President Bill Clinton has served as the keynote speaker.

References[edit]

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Resources[edit]