Masimo

Last updated
Masimo Corporation
Company type Public
Industry
Founded1989;35 years ago (1989)
Founder Joe Kiani
Headquarters
Irvine, California
,
U.S.
Area served
Worldwide
Key people
Michelle Brennan (Member of the Board & Interim CEO)
RevenueIncrease2.svg US$2.05 billion (2023)
Decrease2.svgUS$137 million (2023)
Decrease2.svgUS$82 million (2023)
Total assets Decrease2.svgUS$3.04 billion (2023)
Total equity Increase2.svgUS$1.36 billion (2023)
Number of employees
c. 3,800 (2023)
Website masimo.com
Footnotes /references
Financials as of December 30,2023 [1]

Masimo Corporation is a health technology and consumer electronics company based in Irvine, California. The company primarily manufactures patient monitoring devices and technologies, including non-invasive sensors using optical technology, patient management, and telehealth platforms. In 2022, the company expanded into home audio by acquiring Sound United, and began to manufacture health-oriented wearable devices.

Contents

History

Masimo was founded in 1989 by electrical engineer Joe Kiani, who was later joined by fellow engineer Mohamed Diab. [2]

Masimo went public in 2007 [3] 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. [4] [5]

In 2022, Masimo acquired Sound United, which owns premium audio brands such as Bowers & Wilkins, Denon, Marantz, Definitive Technology, Polk Audio, Classé and Boston Acoustics. The company stated that the acquisition gave it access to more retail channels and product engineers, and that it planned to leverage Denon's HEOS network-connected speakers as smart home hubs for aggregating health data from its services and devices. [6]

In October 2023, the United States International Trade Commission (ITC) ruled that Apple Inc. had infringed upon patents for light-based pulse oximetry owned by Masimo in its Apple Watch product line. Masimo accused Apple of poaching engineers from the company after it declined offers to partner with or be acquired by Apple. Apple denied these claims, stating that it had discussed partnerships with several vendors, and declined to work with Masimo because it was not in the consumer market. [7] [8]

In September 2024, founder and CEO Joe Kiani resigned as CEO following results of a proxy battle. [9] [10]

Technology

Signal Extraction Technology (SET) pulse oximetry

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 to 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 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. [13] [14] Additional studies have also shown the impact of SET on patient outcomes, such as helping clinicians:

  • Decrease retinopathy of prematurity (ROP) in neonates [15] [16]
  • Increase detection of critical congenital heart disease (CCHD) in newborns [17]
  • Reduce ventilator weaning time by titrating FiO2 faster and reduce arterial blood gas measurements in the Intensive Care Unit (ICU) [18]
  • Decrease rapid response activations and Intensive Care Unit (ICU) transfers through earlier identification of patients in distress through low SpO2 and abnormal pulse rate measurements [19] [20]
  • Decrease fluid administered during surgery and reduce patient risk [21]

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". [22] 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. [23]

In 2012, the National Health Service (NHS) Technology Adoption Centre in the United Kingdom advised hospitals to use Intraoperative Fluid Management, and included Masimo's PVI among technologies available for helping clinicians manage fluid during surgeries. [24] In 2013, the French Society for Anaesthesia and Intensive Care (SFAR) added PVI to its guidelines for optimal hemodynamic management of surgical patients. [25]

Rainbow Pulse CO-Oximetry

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). [26] 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%. [27] 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. [28] A study at CHU Limoges  [ fr ] in France found that monitoring with SpHb and PVi, integrated into a hospital-wide fluid and blood administration protocol, was associated with earlier transfusion and reduced mortality at 30 and 90 days by 33% and 29%, respectively. [29] 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. [30] [31] [32] 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. [33] The World Health Organization called noninvasive hemoglobin an "innovative medical technology for cost-effectively addressing global health concerns and needs". [34]

In October 2014, Masimo announced CE Marking 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.[ citation needed ]

Patient and consumer monitoring

SafetyNet

Patient SafetyNet is a remote monitoring and notification system designed for patients on medical/surgical care floors. [35] 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. [36] [37]

In 2020, Dartmouth-Hitchcock published a retrospective study showing that over ten years of using Patient SafetyNet, there were zero patient deaths and no patients were harmed by opioid-induced respiratory depression while continuous monitoring with Masimo SET was in use. [38] ECRI Institute gave Dartmouth its Health Devices Achievement Award for its use of Patient SafetyNet to prevent "severe patient harm". [39] Masimo has introduced Halo ION in the Patient SafetyNet system, combining multiple physiologic parameters into one number to help clinicians assess overall patient status. [40]

In 2020, amid the COVID-19 pandemic, the company released Masimo SafetyNet—a telehealth system for remote patient monitoring via sensors connected to smartphones. The mobile apps transmit this data to a HIPAA-compliant cloud server, allowing it to be monitored by physicians. [41]

Rainbow acoustic monitoring

Rainbow acoustic monitoring provides non-invasive and continuous measurement of respiration rate using an adhesive sensor with an integrated acoustic transducer that is applied to the patient's neck. [42] [43] 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. [44]

SedLine brain function monitoring

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. [45]

Capnography and gas monitoring

Masimo began offering ultra-compact mainstream and sidestream capnography as well as multigas analyzers for end-tidal carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and anesthetic agents, for use in the operating room, procedural sedation, and in intensive care units (ICU). [46] 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. [47]

Opioid monitoring and treatments

In June 2020, the company released Bridge, a medical device intended to reduce symptoms of opioid withdrawal via neuromodulation. [48]

In April 2023, the company received FDA approval for a pulse oximetry-based device for preventing opioid overdose by providing alerts of respiratory depression. The device—which was the subject of an innovation challenge issued by the FDA—received a De Novo classification allowing it to be distributed over-the-counter and through prescription [49]

Smartwatches

In 2022, Masimo released the W1, a smartwatch that includes continuous health monitoring features and integrated with Masimo's other product lines. It was released in a limited public launch in the U.S., and to telehealth providers internationally. [50]

Related Research Articles

<span class="mw-page-title-main">Respiratory failure</span> Inadequate gas exchange by the respiratory system

Respiratory failure results from inadequate gas exchange by the respiratory system, meaning that the arterial oxygen, carbon dioxide, or both cannot be kept at normal levels. A drop in the oxygen carried in the blood is known as hypoxemia; a rise in arterial carbon dioxide levels is called hypercapnia. Respiratory failure is classified as either Type 1 or Type 2, based on whether there is a high carbon dioxide level, and can be acute or chronic. In clinical trials, the definition of respiratory failure usually includes increased respiratory rate, abnormal blood gases, and evidence of increased work of breathing. Respiratory failure causes an altered state of consciousness due to ischemia in the brain.

<span class="mw-page-title-main">Cardiac output</span> Measurement of blood pumped by the heart

In cardiac physiology, cardiac output (CO), also known as heart output and often denoted by the symbols , , or , is the volumetric flow rate of the heart's pumping output: that is, the volume of blood being pumped by a single ventricle of the heart, per unit time. Cardiac output (CO) is the product of the heart rate (HR), i.e. the number of heartbeats per minute (bpm), and the stroke volume (SV), which is the volume of blood pumped from the left ventricle per beat; thus giving the formula:

<span class="mw-page-title-main">Methemoglobinemia</span> Condition of elevated methemoglobin in the blood

Methemoglobinemia, or methaemoglobinaemia, is a condition of elevated methemoglobin in the blood. Symptoms may include headache, dizziness, shortness of breath, nausea, poor muscle coordination, and blue-colored skin (cyanosis). Complications may include seizures and heart arrhythmias.

<span class="mw-page-title-main">Intensive care medicine</span> Medical care subspecialty, treating critically ill

Intensive care medicine, also called critical care medicine, is a medical specialty that deals with seriously or critically ill patients who have, are at risk of, or are recovering from conditions that may be life-threatening. It includes providing life support, invasive monitoring techniques, resuscitation, and end-of-life care. Doctors in this specialty are often called intensive care physicians, critical care physicians, or intensivists.

<span class="mw-page-title-main">Arterial blood gas test</span> A test of blood taken from an artery that measures the amounts of certain dissolved gases

An arterial blood gas (ABG) test, or arterial blood gas analysis (ABGA) measures the amounts of arterial gases, such as oxygen and carbon dioxide. An ABG test requires that a small volume of blood be drawn from the radial artery with a syringe and a thin needle, but sometimes the femoral artery in the groin or another site is used. The blood can also be drawn from an arterial catheter.

<span class="mw-page-title-main">Photoplethysmogram</span> Chart of tissue blood volume changes

A photoplethysmogram (PPG) is an optically obtained plethysmogram that can be used to detect blood volume changes in the microvascular bed of tissue. A PPG is often obtained by using a pulse oximeter which illuminates the skin and measures changes in light absorption. A conventional pulse oximeter monitors the perfusion of blood to the dermis and subcutaneous tissue of the skin.

Carboxyhemoglobin is a stable complex of carbon monoxide and hemoglobin (Hb) that forms in red blood cells upon contact with carbon monoxide. Carboxyhemoglobin is often mistaken for the compound formed by the combination of carbon dioxide (carboxyl) and hemoglobin, which is actually carbaminohemoglobin. Carboxyhemoglobin terminology emerged when carbon monoxide was known by its historic name, "carbonic oxide", and evolved through Germanic and British English etymological influences; the preferred IUPAC nomenclature is carbonylhemoglobin.

<span class="mw-page-title-main">Blue baby syndrome</span> Two situations that lead to cyanosis in infants

Blue baby syndrome can refer to conditions that cause cyanosis, or blueness of the skin, in babies as a result of low oxygen levels in the blood. This term has traditionally been applied to cyanosis as a result of:.

  1. Cyanotic heart disease, which is a category of congenital heart defect that results in low levels of oxygen in the blood. This can be caused by either reduced blood flow to the lungs or mixing of oxygenated and deoxygenated blood.
  2. Methemoglobinemia, which is a disease defined by high levels of methemoglobin in the blood. Increased levels of methemoglobin prevent oxygen from being released into the tissues and result in hypoxemia.
<span class="mw-page-title-main">Pulse oximetry</span> Measurement of blood oxygen saturation

Pulse oximetry is a noninvasive method for monitoring blood oxygen saturation. Peripheral oxygen saturation (SpO2) readings are typically within 2% accuracy of the more accurate reading of arterial oxygen saturation (SaO2) from arterial blood gas analysis.

<span class="mw-page-title-main">Hypocapnia</span> State of reduced carbon dioxide in the blood

Hypocapnia, also known as hypocarbia, sometimes incorrectly called acapnia, is a state of reduced carbon dioxide in the blood. Hypocapnia usually results from deep or rapid breathing, known as hyperventilation.

<span class="mw-page-title-main">Capnography</span> Monitoring of the concentration of carbon dioxide in respiratory gases

Capnography is the monitoring of the concentration or partial pressure of carbon dioxide (CO
2) in the respiratory gases. Its main development has been as a monitoring tool for use during anesthesia and intensive care. It is usually presented as a graph of CO
2 (measured in kilopascals, "kPa" or millimeters of mercury, "mmHg") plotted against time, or, less commonly, but more usefully, expired volume (known as volumetric capnography). The plot may also show the inspired CO
2, which is of interest when rebreathing systems are being used. When the measurement is taken at the end of a breath (exhaling), it is called "end tidal" CO
2 (PETCO2).

<span class="mw-page-title-main">Vital signs</span> Group of medical indicators

Vital signs are a group of the four to six most crucial medical signs that indicate the status of the body's vital (life-sustaining) functions. These measurements are taken to help assess the general physical health of a person, give clues to possible diseases, and show progress toward recovery. The normal ranges for a person's vital signs vary with age, weight, sex, and overall health.

Hyperoxia is the state of being exposed to high levels of oxygen; it may refer to organisms, cells and tissues that are experiencing excessive oxygenation, or to an abnormally high oxygen concentration in an environment.

<span class="mw-page-title-main">CO-oximeter</span>

A CO-oximeter is a device that measures the oxygen carrying state of hemoglobin in a blood specimen, including oxygen-carrying hemoglobin (O2Hb), non-oxygen-carrying but normal hemoglobin (HHb), as well as the dyshemoglobins such as carboxyhemoglobin (COHb) and methemoglobin (MetHb). The use of 'CO' rather than 'Co' or 'co' is more appropriate since this designation represents a device that measures carbon monoxide (CO) bound to hemoglobin, as distinguished from simple oximetry which measures hemoglobin bound to molecular oxygen—O2Hb—or hemoglobin capable of binding to molecular oxygen—HHb. Simpler oximeters may report oxygen saturation alone, i.e. the ratio of oxyhemoglobin to total 'bindable' hemoglobin. CO-oximetry is useful in defining the causes for hypoxemia, or hypoxia,.

<span class="mw-page-title-main">Simple face mask</span> Plastic mask for oxygen therapy

The simple face mask (SFM) is a basic disposable mask, made of clear plastic, to provide oxygen therapy for patients who are experiencing conditions such as chest pain, dizziness, and minor hemorrhages. This mask is only meant for patients who are able to breathe on their own, but who may require a higher oxygen concentration than the 21% concentration found in ambient air. Patients who are unable to breathe on their own are placed on a medical ventilator instead. The simple face mask can deliver higher flow rates than nasal cannula for an FiO2 of 30- 60% oxygen. Nasal cannula and simple face masks are described as low flow delivery systems.

<span class="mw-page-title-main">Joe Kiani</span> Iranian-born American entrepreneur (born 1964)

Massi Kiani, known as Joe Kiani, is an Iranian-born American engineer, entrepreneur, and corporate executive. He is the founder of medical technology company Masimo, which was initially established in 1989. In 2021, he was appointed by President Joe Biden to serve on the President's Council of Advisors on Science and Technology (PCAST).

<span class="mw-page-title-main">Oxygen saturation (medicine)</span> Medical measurement

Oxygen saturation is the fraction of oxygen-saturated haemoglobin relative to total haemoglobin in the blood. The human body requires and regulates a very precise and specific balance of oxygen in the blood. Normal arterial blood oxygen saturation levels in humans are 96–100 percent. If the level is below 90 percent, it is considered low and called hypoxemia. Arterial blood oxygen levels below 80 percent may compromise organ function, such as the brain and heart, and should be promptly addressed. Continued low oxygen levels may lead to respiratory or cardiac arrest. Oxygen therapy may be used to assist in raising blood oxygen levels. Oxygenation occurs when oxygen molecules enter the tissues of the body. For example, blood is oxygenated in the lungs, where oxygen molecules travel from the air and into the blood. Oxygenation is commonly used to refer to medical oxygen saturation.

<span class="mw-page-title-main">Monitoring (medicine)</span> Observation of a disease, condition or one or several medical parameters over time

In medicine, monitoring is the observation of a disease, condition or one or several medical parameters over time.

Blood gas tension refers to the partial pressure of gases in blood. There are several significant purposes for measuring gas tension. The most common gas tensions measured are oxygen tension (PxO2), carbon dioxide tension (PxCO2) and carbon monoxide tension (PxCO). The subscript x in each symbol represents the source of the gas being measured: "a" meaning arterial, "A" being alveolar, "v" being venous, and "c" being capillary. Blood gas tests (such as arterial blood gas tests) measure these partial pressures.

The Newborn Foundation is a Minnesota-based international 501(c)(3) non-profit organization that advocates for newborn screening and works to develop and implement programs, technologies and policies that reduce infant mortality. The organization has played a part in the addition of universal newborn pulse oximetry (CCHD) screening to the federal Routine Uniform Screening Panel (RUSP).

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  46. ↑ "Masimo enters noninvasive multigas monitoring, including capnography, with acquisition of PHASEIN". Medcitynews.com. 2012-08-01. Archived from the original on 2013-01-28. Retrieved 2012-08-05.
  47. ↑ Patino, M; Redford, DT; Quigley, TW; Mahmoud, M; Kurth, CD; Szmuk, P (Dec 2013). "Accuracy of acoustic respiration rate monitoring in pediatric patients". Paediatr Anaesth. 23 (12): 1166–73. doi: 10.1111/pan.12254 . PMID   24033591. S2CID   21984397.
  48. ↑ "Masimo announces device designed to reduce opioid withdrawal symptoms". MobiHealthNews. 2020-06-29. Retrieved 2022-05-19.
  49. ↑ Hale, Conor (2023-04-03). "Masimo receives FDA clearance for first opioid overdose prevention monitor". Firece Biotech. Questex LLC. Retrieved May 15, 2023.
  50. ↑ "Masimo Launches Health Watch for Consumers on a Limited Basis". mddionline.com. 2022-05-02. Retrieved 2022-05-19.
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