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Masimo

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Masimo Corporation
Company typePublic
Industry
Founded1989; 35 years ago (1989)
FounderJoe Kiani
Headquarters
Irvine, California
,
U.S.
Area served
Worldwide
Key people
Michelle Brennan (Member of the Board & Interim CEO)
RevenueIncrease US$2.05 billion (2023)
Decrease US$137 million (2023)
Decrease US$82 million (2023)
Total assetsDecrease US$3.04 billion (2023)
Total equityIncrease US$1.36 billion (2023)
Number of employees
c. 3,800 (2023)
Websitemasimo.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.

History

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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

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Signal Extraction Technology (SET) pulse oximetry

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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

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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

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SafetyNet

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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

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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

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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

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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

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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

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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]

References

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  1. ^ "Masimo Corp 2023 Annual Report (Form 10-K)". U.S. Securities and Exchange Commission. 2024-02-28.
  2. ^ "Masimo's Kiani: Stared Down Tyco". Orange County Business Journal. March 19, 2006.
  3. ^ "Joe Kiani, CEO, Chairman and Founder of Masimo Corporation, rings the NASDAQ opening bell". Nasdaq.com. 2008-08-07.
  4. ^ Badenhausen, K (2011-10-19). "The top 20 small public companies in America". Forbes.com.
  5. ^ Badenhausen, K (2011-10-19). "#19 Masimo". Forbes.com.
  6. ^ Newmarker, Chris (2022-12-14). "Masimo will turn millions of home entertainment systems into health hubs". MassDevice. Retrieved 2023-12-19.
  7. ^ Harding, Scharon (2023-10-27). "Apple Watch facing potential ban after losing Masimo patent case". Ars Technica. Retrieved 2023-12-18.
  8. ^ Song, Victoria (2023-12-18). "Apple to pull Apple Watch Series 9 and Ultra 2 this week due to ITC ban". The Verge. Retrieved 2023-12-18.
  9. ^ "Masimo Provides Leadership and Business Updates".
  10. ^ Gatlin, Allison. "Masimo CEO Joe Kiani Resigns Following Politan Proxy Battle; Shares Jump".
  11. ^ Mardirossian, G; Schneider, RE (1992). "Limitations of pulse oximetry". Anesth Prog. 39 (6): 194–6. PMC 2148612. PMID 8250340.
  12. ^ Barker, SJ; Tremper, KK (1987). "Pulse oximetry: Applications and limitations". Int Anesthesiol Clin. 25 (3): 155–75. doi:10.1097/00004311-198702530-00010. PMID 3323062. S2CID 42950128.
  13. ^ Malviya, S; Reynolds, PI; Voepel-Lewis, T; Siewert, M; Watson, D; Tait, AR; Tremper, K (2000). "False alarms and sensitivity of conventional pulse oximetry versus the SET technology in the pediatric postanesthesia care unit". Anesth Analg. 90 (6): 1336–40. doi:10.1097/00000539-200006000-00013. PMID 10825316. S2CID 24290526.
  14. ^ Barker, SJ (2002). ""Motion-resistant" pulse oximetry: a comparison of old and new models". Anesth Analg. 95 (4): 967–72. doi:10.1213/00000539-200210000-00033. PMID 12351278. S2CID 13103745.
  15. ^ Castillo, A; Deulofeut, R; Critz, A; Sola, A (2011). "Prevention of retinopathy of prematurity in preterm infants through changes in clinical practice and SpO2 technology". Acta Paediatrica. 100 (2): 188–92. doi:10.1111/j.1651-2227.2010.02001.x. PMC 3040295. PMID 20825604.
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  17. ^ De-Wahl, GA; Wennergren, M; Sandberg, K; Mellander, M; Bejlum, C; Inganas, L; Eriksson, M; Segerdahl, N; Agren, A; Ekman-Joelsson, BM; Sunnegardh, J; Verdicchio, M; Ostman-Smith, I (2009). "Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: A Swedish prospective screening study in 39,821 newborns". Br Med J. 338: a3037. doi:10.1136/bmj.a3037. PMC 2627280. PMID 19131383.
  18. ^ 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. PMID 12163785. S2CID 10226994.
  19. ^ Taenzer, AH; Pyke, JB; McGrath, SP; Blike, GT (2010). "Impact of pulse oximetry surveillance on rescue events and intensive care unit (ICU) transfers: A before-and-after concurrence study". Anesthesiology. 112 (2): 282–87. doi:10.1097/ALN.0b013e3181ca7a9b. PMID 20098128.
  20. ^ Taenzer, AH; Blike, GT (2012). "Postoperative monitoring – the Dartmouth experience". APSF Spring-Summer Newsletter.
  21. ^ Forget, P; Lois, F; De Kock, M (2010). "Goal-directed fluid management based on the pulse oximeter–derived pleth variability index reduces lactate levels and improves fluid management". Anesth Analg. 111 (4): 910–4. doi:10.1213/ANE.0b013e3181eb624f. PMID 20705785. S2CID 40761008.
  22. ^ Ewer, AK; Furmston, AT; Middleton, LJ; Deeks, J; Daniels, JP; Pattison, HM; Powell, R; Roberts, TE; Parton, P; Auguste, P; Bhoyar, A; Thangaratinam, S; Tonks, AM; Satodia, P; Deshpande, S; Kumararatne, B; Sivakumar, S; Mupanemunda, R; Khan, KS (2012). "Pulse oximetry as a screening test for congenital heart defects in newborn infants: a test accuracy study with evaluation of acceptability and cost-effectiveness". Health Technol Assess. 16 (2): 1–184. doi:10.3310/hta16020. PMID 22284744.
  23. ^ "Masimo oximeters and neonatal sensors receive FDA 510(k) clearance with labeling for use in newborn screening for Critical Congenital Heart Disease (CCHD)" (Press release). PRNewswire.com. 2012-09-26.
  24. ^ "IOFM technology adoption pack published". Ntac.nhs.uk. Archived from the original on 2012-09-06. Retrieved 2012-08-05.
  25. ^ Vallet, B; Blanloeil, Y; Cholley, B; Orliaguet, G; Pierre, S; Tavernier, B (October 2013). "Guidelines for perioperative haemodynamic optimization" (PDF). Annales Françaises d'Anesthésie et de Réanimation. 32 (10): e151 – e158. doi:10.1016/j.annfar.2013.09.010. PMID 24126197. S2CID 43268634.
  26. ^ "Masimo Rainbow SET Pulse CO-Oximetry technology shown effective and efficient in detecting carbon monoxide poisoning in multiple clinical settings". Medicalnewstoday.com. Retrieved 2012-08-05.
  27. ^ "Anesthesiology News". Anesthesiology News. Retrieved 2012-08-05.
  28. ^ Awada, WNFM; Maher, F (2013). "Reduction in red blood cell transfusions during neurosurgery with noninvasive and continuous hemoglobin monitoring". p. 51.
  29. ^ 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. ISSN 1573-2614. PMID 31376030. S2CID 199389128.
  30. ^ 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. PMID 18226877.
  31. ^ Roth, D; Schreiber, W; Herkner, H; Havel, C (2014). "Prevalence of carbon monoxide poisoning in patients presenting to a large emergency department". Int J Clin Pract. 68 (10): 1239–45. doi:10.1111/ijcp.12432. PMID 24698635. S2CID 8935069.
  32. ^ 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. PMID 22626815.
  33. ^ "Award winners | medical design excellence awards". Canontradeshows.com. 2005-10-22. Retrieved 2012-08-05.
  34. ^ "Noninvasive hemoglobin test (first ouchless & bloodless) makes world health organization's (WHO) list of innovative medical technologies that address global health concerns and needs…". www.healthcarereview.com. 2010-08-31. Archived from the original on 2011-01-01. Retrieved 2011-03-20.
  35. ^ Ostrovsky, G (2007-10-17). "Masimo Patient SafetyNet". Medgadget.com. Archived from the original on 2007-12-23. Retrieved 2008-01-04.
  36. ^ "Geisel School of Medicine - Closer watch, fewer Intensive Care Unit (ICU) trips, Dartmouth anesthesiologists find". Dms.dartmouth.edu. 2010-03-05.
  37. ^ "APSF Newsletter Spring-Summer 2012". Apsf.org. Retrieved 2012-08-05.
  38. ^ McGrath, Susan P.; McGovern, Krystal M.; Perreard, Irina M.; Huang, Viola; Moss, Linzi B.; Blike, George T. (2020-03-14). "Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity". Journal of Patient Safety. 17 (8): 557–561. doi:10.1097/PTS.0000000000000696. ISSN 1549-8425. PMC 8612899. PMID 32175965.
  39. ^ "ECRI Institute announces winner of 4th annual health devices achievement award". Ecri.org. Archived from the original on 2012-12-20. Retrieved 2012-08-05.
  40. ^ Ostrovsky, G (2010-10-14). "Masimo to Release New Halo Index, Radical 7 Pulse Oximeter, Patient SafetyNet Monitoring System". Medgadget.com. Archived from the original on 2011-02-21. Retrieved 2011-05-13.
  41. ^ Whooley, Sean (2022-07-05). "Masimo's SafetyNet monitoring reduced length of COVID-19 hospital stays, study says". MassDevice. Retrieved 2023-12-19.
  42. ^ "FDA clears Masimo Rainbow SET Acoustic Respiration Rate Monitor | News | RT: for decision makers in respiratory care". Rtmagazine.com. Archived from the original on 2012-03-21. Retrieved 2012-08-05.
  43. ^ Kumpula, JC; Rhonda, D; Harrison, RD (2010-10-18). "Accuracy of acoustic respiration rate monitoring in an acute nursing unit" (Abstract). ASA Abstracts. A1079.
  44. ^ Goudra, B; Penugonda, L (2011). "Monitoring respiration in upper GI endoscopy anesthesia" (ASA Presentation). A246.
  45. ^ Drover, DR; Lemmens, HJ; Pierce, ET; Plourde, G; Loyd, G; Ornstein, E; Prichep, LS; Chabot, RJ; Gugino, L (2002). "Patient state index: Titration of delivery and recovery from propofol, alfentanil, and nitrous oxide anesthesia". Anesthesiology. 97 (1): 82–9. doi:10.1097/00000542-200207000-00012. PMID 12131107. S2CID 3019914.
  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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