Masimo Corporation is an Americanhealth technology andconsumer electronics company headquartered inIrvine, California. The company develops patient monitoring devices,non-invasive sensors, and related software platforms used in hospital and home settings. Masimo has also operated in the consumer audio and wearable device markets.
Masimo was founded in 1989 by engineerJoe Kiani; Mohamed Diab later joined as a co-developer.[2]
The company became publicly traded in 2007[3] and is listed on theNasdaq under the ticker MASI. In 2011,Forbes included Masimo in a ranking of small public companies in the United States.[4][5]
In October 2023, theUnited States International Trade Commission (ITC) ruled thatApple Inc. had infringed patents held by Masimo related to light-based pulse oximetry in theApple Watch product line. Masimo stated that Apple had recruited some of its engineers after discussions about a possible partnership, while Apple said it had evaluated multiple vendors and did not select Masimo.[7][8]
In September 2024, founder and CEO Joe Kiani resigned following a proxy contest involving an activist investor.[9][10]
Pulse oximetry estimates arterial oxygen saturation ([[SpO2]]) by comparing the absorption of red and infrared light. Motion and low perfusion can affect conventional pulse oximetry because venous blood movement may alter the signal.[12][13]
Masimo’s Signal Extraction Technology (SET) uses signal-processing algorithms to distinguish arterial from venous signals and to estimate SpO2, pulse rate, perfusion index (PI) and pleth variability index (PVI). Multiple clinical studies, mostly single-center or manufacturer-associated trials, have reported lower false-alarm rates and improved measurement stability compared with some earlier pulse oximetry systems, particularly in motion and low-perfusion conditions.[14][15]
SET-based devices have been studied in neonatology, perioperative care and intensive care. Individual studies have reported associations between use of these devices and outcomes such as changes in the incidence ofretinopathy of prematurity in preterm infants, detection ofcritical congenital heart disease (CCHD) in newborns, ventilator weaning practices, and rapid-response activations in hospital wards.[16][17][18][19][20][21]
In 2011, theAmerican Academy of Pediatrics and theU.S. Department of Health and Human Services recommended universal newborn screening for CCHD using motion-tolerant pulse oximeters validated in low-perfusion conditions.[22] In 2012, Masimo receivedFDA 510(k) clearance for devices and sensors labeled for use in screening newborns for CCHD in conjunction with a physical examination.[23]
In 2012, theNational Health Service (NHS) Technology Adoption Centre in the United Kingdom included Masimo’s PVI among options for intraoperative fluid management technologies,[24] and in 2013 the French Society for Anaesthesia and Intensive Care (SFAR) noted PVI in its guidelines on perioperative hemodynamic optimization.[25]
Rainbow pulse co-oximetry uses multiple wavelengths of light to estimate several parameters noninvasively, including total hemoglobin (SpHb),carboxyhemoglobin (SpCO), andmethemoglobin (SpMet), in addition to oxygen saturation (SpO2), pulse rate, perfusion index (PI) and pleth variability index (PVI).[26]
Several clinical studies have evaluated SpHb monitoring in perioperative and critical care settings, reporting reductions in the proportion of patients receiving transfusions and in transfusion volumes when SpHb was incorporated into transfusion protocols.[27][28][29] Studies inEmergency department settings have reported that SpCO monitoring may increase the detection of carbon monoxide poisoning and shorten time to diagnosis compared with some conventional approaches.[30][31][32]
The Pronto-7 device for noninvasive spot-checking of hemoglobin, SpO2 and pulse rate received a gold Medical Design Excellence Award,[33] and theWorld Health Organization listed noninvasive hemoglobin testing among technologies relevant to global health needs.[34]
Patient SafetyNet is a remote monitoring and notification system used on medical–surgical care floors.[35] A study atDartmouth-Hitchcock Medical Center reported a reduction in distress codes and intensive care transfers and estimated cost savings after implementing continuous monitoring with SET-based devices and Patient SafetyNet.[36][37]
A 2020 retrospective study at Dartmouth-Hitchcock examining sedative- and analgesic-associated inpatient respiratory arrest found that, during a ten-year period in which continuous monitoring with Masimo SET was used, no deaths or severe morbidity from opioid-induced respiratory depression were observed in monitored patients.[38] TheECRI Institute recognized Dartmouth’s use of the system with a Health Devices Achievement Award.[39]
During theCOVID-19 pandemic, Masimo introduced Masimo SafetyNet, a telehealth system for remote patient monitoring that uses sensors connected tosmartphones, with data transmitted to aHIPAA-compliantcloud platform.[40]
Masimo’s acoustic respiration monitoring technology provides noninvasive, continuous measurement ofrespiration rate using an adhesive sensor with an integratedacoustic transducer placed on the patient’s neck.[41][42] Studies have reported that acoustic respiration rate monitoring has comparable accuracy and fewer false alarms than some respiration monitoring methods such as nasal capnography and impedance pneumography in selected patient groups.[43][44]
SedLine is a brain function monitoring system that analyzesEEG activity from both hemispheres to derive an index of anesthetic depth.[45] Research has explored its use in tailoring anesthetic dosing and assessing emergence from anesthesia.
Masimo offers mainstream and sidestreamcapnography and multigas analyzers for measurement of end-tidalcarbon dioxide (CO2),nitrous oxide (N2O), oxygen (O2) and volatile anesthetic agents in operating rooms, procedural sedation environments and intensive care units.[46] A multi-center pediatric study reported that acoustic respiration rate had similar accuracy and precision to nasal capnography in certain settings.[47]
In June 2020, Masimo released Bridge, a neuromodulation device intended to reduce symptoms ofopioid withdrawal.[48]
In April 2023, the company received FDADe Novo clearance for a pulse-oximetry-based device designed to alert to respiratory depression as a potential early indicator ofopioid overdose. The device was authorized for both prescription andover-the-counter distribution.[49]
In 2022, Masimo released the W1smartwatch, which incorporates continuous physiological monitoring features and integrates with the company’s other monitoring platforms. The launch initially targeted a limited consumer release in the United States and telehealth providers internationally.[50]
^Durbin, CG; Rostow, SK (2002). "More reliable oximetry reduces the frequency of arterial blood gas analysis and hastens oxygen weaning following cardiac surgery; a prospective randomize trial of the clinical impact of a new technology".Crit Care Med.30 (8):1735–40.doi:10.1097/00003246-200208000-00010.PMID12163785.S2CID10226994.
^Awada, WNFM; Maher, F (2013). "Reduction in red blood cell transfusions during neurosurgery with noninvasive and continuous hemoglobin monitoring". p. 51.
^Cros, Jérôme; Dalmay, François; Yonnet, Sandra; Charpentier, Matthieu; Tran-Van-Ho, Jessica; Renaudeau, François; Drouet, Anais; Guilbaut, Pierre; Marin, Benoit; Nathan, Nathalie (2019-08-03). "Continuous hemoglobin and plethysmography variability index monitoring can modify blood transfusion practice and is associated with lower mortality".Journal of Clinical Monitoring and Computing.34 (4):683–691.doi:10.1007/s10877-019-00367-z.ISSN1573-2614.PMID31376030.S2CID199389128.
^Suner, S; Partridge, R; Sucov, A; Valente, J; Chee, K; Hughes, A; Jay, G (2008). "Non-invasive pulse co-oximetry screening in the emergency department identifies occult carbon monoxide toxicity".J Emerg Med.34 (4):441–50.doi:10.1016/j.jemermed.2007.12.004.PMID18226877.
^Hampson, N (2012). "Noninvasive pulse co-oximetry expedites evaluation and management of patients with carbon monoxide poisoning".Am J Emerg Med.30 (9):2021–4.doi:10.1016/j.ajem.2012.03.026.PMID22626815.
US$2.09 billion (2024)
US$−267 million (2024)