Masimo Explained

Masimo Corporation
Logo Alt:Masimo logo
Type:Public
Founder:Joe Kiani
Location City:Irvine, California
Location Country:U.S.
Area Served:Worldwide
Num Employees: (2023)
Operating Income: (2023)
Net Income: (2023)
Assets: (2023)
Equity: (2023)
Footnotes:Financials [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

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]

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.[9] [10]

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.[11] [12] Additional studies have also shown the impact of SET on patient outcomes, such as helping clinicians:

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".[20] 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.[21]

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.[22] In 2013, the French Society for Anaesthesia and Intensive Care (SFAR) added PVI to its guidelines for optimal hemodynamic management of surgical patients.[23]

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).[24] 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%.[25] 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.[26] A study at 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.[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 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.

Patient and consumer monitoring

SafetyNet

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]

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.[36] ECRI Institute gave Dartmouth its Health Devices Achievement Award for its use of Patient SafetyNet to prevent "severe patient harm".[37] Masimo has introduced Halo ION in the Patient SafetyNet system, combining multiple physiologic parameters into one number to help clinicians assess overall patient status.[38]

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.[39]

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.[40] [41] 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.[42]

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.[43]

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).[44] 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.[45]

Opioid monitoring and treatments

In June 2020, the company released Bridge, a medical device intended to reduce symptoms of opioid withdrawal via neuromodulation.[46]

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[47]

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.[48]

Notes and References

  1. Web site: Masimo Corp 2023 Annual Report (Form 10-K) . 2024-02-28 . U.S. Securities and Exchange Commission.
  2. Web site: Masimo's Kiani: Stared Down Tyco. March 19, 2006. Orange County Business Journal.
  3. Web site: Joe Kiani, CEO, Chairman and Founder of Masimo Corporation, rings the NASDAQ opening bell . Nasdaq.com . 2008-08-07.
  4. Web site: The top 20 small public companies in America . Forbes.com. K. Badenhausen. 2011-10-19.
  5. Web site:
    1. 19 Masimo
    . Forbes.com. K. Badenhausen. 2011-10-19.
  6. Web site: Newmarker . Chris . 2022-12-14 . Masimo will turn millions of home entertainment systems into health hubs . 2023-12-19 . MassDevice . en-US.
  7. Web site: Harding . Scharon . 2023-10-27 . Apple Watch facing potential ban after losing Masimo patent case . 2023-12-18 . Ars Technica . en-us.
  8. Web site: Song . Victoria . 2023-12-18 . Apple to pull Apple Watch Series 9 and Ultra 2 this week due to ITC ban . 2023-12-18 . The Verge . en.
  9. 2148612 . G . Mardirossian . RE . Schneider . 1992. Limitations of pulse oximetry . Anesth Prog . 39 . 6 . 194–6 . 8250340.
  10. 3323062 . 1987 . Barker . SJ . Tremper . KK . Pulse oximetry: Applications and limitations . 25 . 3 . 155–75 . Int Anesthesiol Clin . 10.1097/00004311-198702530-00010. 42950128 .
  11. 10825316 . 2000 . Malviya . S . Reynolds . PI . Voepel-Lewis . T . Siewert . M . Watson . D . Tait . AR . Tremper . K . False alarms and sensitivity of conventional pulse oximetry versus the SET technology in the pediatric postanesthesia care unit . Anesth Analg . 90 . 6 . 1336–40 . 10.1097/00000539-200006000-00013. 24290526 . free .
  12. Barker . SJ . 2002. "Motion-resistant" pulse oximetry: a comparison of old and new models . Anesth Analg . 95 . 4 . 967–72 . 12351278 . 10.1213/00000539-200210000-00033. 13103745 . free .
  13. 10.1111/j.1651-2227.2010.02001.x . Prevention of retinopathy of prematurity in preterm infants through changes in clinical practice and SpO2 technology . 2011 . Castillo . A . Deulofeut . R . Critz . A . Sola . A . Acta Paediatrica . 100 . 2 . 188–92 . 20825604 . 3040295.
  14. 10.1038/jp.2013.122. 24071904 . Temporal quantification of oxygen saturation ranges: an effort to reduce hyperoxia in the neonatal intensive care unit . 2013 . Bizzarro . M . Ly . F . Katz . K . Shabanova . V . Ehrenkranz . R . Bhandari . V . J Perinatol . 34 . 1 . 33–8. 7240789 .
  15. 10.1136/bmj.a3037 . 19131383 . 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. 2627280 .
  16. 10.1097/00003246-200208000-00010. 12163785 . 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. 10226994 .
  17. 10.1097/ALN.0b013e3181ca7a9b. 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 . 20098128. free .
  18. News: Taenzer . AH . Blike . GT . 2012 . Postoperative monitoring – the Dartmouth experience . APSF Spring-Summer Newsletter.
  19. 10.1213/ANE.0b013e3181eb624f . 20705785 . 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 . 40761008 . free .
  20. 10.3310/hta16020. 22284744 . 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. free .
  21. Masimo oximeters and neonatal sensors receive FDA 510(k) clearance with labeling for use in newborn screening for Critical Congenital Heart Disease (CCHD) . PRNewswire.com . 2012-09-26.
  22. Web site: IOFM technology adoption pack published . Ntac.nhs.uk . 2012-08-05 . http://webarchive.nationalarchives.gov.uk/20120906074150/http%3A//www.ntac.nhs.uk/NewsAndEvents/IOFM_Technology_Adoption_Pack_Published.aspx . 2012-09-06 .
  23. Vallet . B . Blanloeil . Y . Cholley . B . Orliaguet . G . Pierre . S . Tavernier . B . October 2013 . Guidelines for perioperative haemodynamic optimization . Annales Françaises d'Anesthésie et de Réanimation . 32 . 10 . e151–e158 . 10.1016/j.annfar.2013.09.010 . 24126197 . 43268634 .
  24. Web site: Masimo Rainbow SET Pulse CO-Oximetry technology shown effective and efficient in detecting carbon monoxide poisoning in multiple clinical settings . Medicalnewstoday.com . 2012-08-05.
  25. Web site: Anesthesiology News . Anesthesiology News . 2012-08-05.
  26. News: Awada . WNFM . Maher . F . 2013 . Reduction in red blood cell transfusions during neurosurgery with noninvasive and continuous hemoglobin monitoring. 51.
  27. 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. en. 10.1007/s10877-019-00367-z. 31376030. 199389128. 1573-2614.
  28. 18226877 . 10.1016/j.jemermed.2007.12.004 . 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.
  29. 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 . 10.1111/ijcp.12432 . 24698635. 8935069 . free .
  30. 10.1016/j.ajem.2012.03.026 . 22626815 . 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.
  31. Web site: Award winners | medical design excellence awards . Canontradeshows.com . 2005-10-22 . 2012-08-05.
  32. News: Noninvasive hemoglobin test (first ouchless & bloodless) makes world health organization's (WHO) list of innovative medical technologies that address global health concerns and needs… . 2010-08-31 . www.healthcarereview.com . 2011-03-20 . https://web.archive.org/web/20110101042220/http://www.healthcarereview.com/2010/08/noninvasive-hemoglobin-test-first-ouchless-bloodless-makes-world-health-organizations-who-list-of-innovative-medical-technologies-that-address-global-health-concerns-and-needs/ . 2011-01-01 .
  33. Web site: Masimo Patient SafetyNet . Ostrovsky . G . 2007-10-17 . Medgadget.com . 2008-01-04 . https://web.archive.org/web/20071223123706/http://www.medgadget.com/archives/2007/10/masimo_patient_safetynet.html . 2007-12-23 .
  34. Web site: Geisel School of Medicine - Closer watch, fewer Intensive Care Unit (ICU) trips, Dartmouth anesthesiologists find . 2010-03-05 . Dms.dartmouth.edu.
  35. Web site: APSF Newsletter Spring-Summer 2012 . Apsf.org . 2012-08-05.
  36. 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 . 10.1097/PTS.0000000000000696. 1549-8425. 32175965. 8612899 . free.
  37. Web site: ECRI Institute announces winner of 4th annual health devices achievement award . Ecri.org . 2012-08-05 . https://archive.today/20121220164135/https://www.ecri.org/Press/Pages/Health_Devices_Award_Winner_2009.aspx . 2012-12-20 .
  38. Web site: Masimo to Release New Halo Index, Radical 7 Pulse Oximeter, Patient SafetyNet Monitoring System . Ostrovsky . G . 2010-10-14 . Medgadget.com . 2011-05-13 . https://web.archive.org/web/20110221075415/http://www.medgadget.com/archives/2010/10/masimo_to_release_new_halo_index_radical_7_pulse_oximeter_patient_safetynet_monitoring_system.html . 2011-02-21 .
  39. Web site: Whooley . Sean . 2022-07-05 . Masimo's SafetyNet monitoring reduced length of COVID-19 hospital stays, study says . 2023-12-19 . MassDevice . en-US.
  40. Web site: FDA clears Masimo Rainbow SET Acoustic Respiration Rate Monitor | News | RT: for decision makers in respiratory care . Rtmagazine.com . 2012-08-05 . https://web.archive.org/web/20120321162436/http://www.rtmagazine.com/news/2009-12-01_01.asp . 2012-03-21 .
  41. Web site: Accuracy of acoustic respiration rate monitoring in an acute nursing unit . Kumpula . JC . Rhonda . D . Harrison . RD . 2010-10-18 . ASA Abstracts . Abstract . A1079.
  42. News: Goudra. B. Penugonda. L. 2011. Monitoring respiration in upper GI endoscopy anesthesia. ASA Presentation. A246.
  43. 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 . 12131107 . 10.1097/00000542-200207000-00012. 3019914 . free .
  44. Web site: Masimo enters noninvasive multigas monitoring, including capnography, with acquisition of PHASEIN . 2012-08-01 . Medcitynews.com . 2012-08-05 . https://archive.today/20130128144750/http://medcitynews.com/2012/08/masimo-enters-noninvasive-multigas-monitoring-including-capnography-with-acquisition-of-phasein/ . 2013-01-28 .
  45. 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 . 10.1111/pan.12254 . 24033591. 21984397 . free .
  46. Web site: 2020-06-29 . Masimo announces device designed to reduce opioid withdrawal symptoms . 2022-05-19 . MobiHealthNews . en.
  47. Web site: Hale . Conor . 2023-04-03 . Masimo receives FDA clearance for first opioid overdose prevention monitor . May 15, 2023 . Firece Biotech . Questex LLC.
  48. Web site: 2022-05-02 . Masimo Launches Health Watch for Consumers on a Limited Basis . 2022-05-19 . mddionline.com . en.

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