Masimo

Signal Extraction Technology (SET) pulse oximetry

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.^[13][14]

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.^[15][16]

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 of retinopathy of prematurity in preterm infants, detection of critical congenital heart disease (CCHD) in newborns, ventilator weaning practices, and rapid-response activations in hospital wards.^{[17][18][19][20][21][22]}

In 2011, the American Academy of Pediatrics and the U.S. Department of Health and Human Services recommended universal newborn screening for CCHD using motion-tolerant pulse oximeters validated in low-perfusion conditions.^[23] In 2012, Masimo received FDA 510(k) clearance for devices and sensors labeled for use in screening newborns for CCHD in conjunction with a physical examination.^[24]

In 2012, the National Health Service (NHS) Technology Adoption Centre in the United Kingdom included Masimo’s PVI among options for intraoperative fluid management technologies,^[25] and in 2013 the French Society for Anaesthesia and Intensive Care (SFAR) noted PVI in its guidelines on perioperative hemodynamic optimization.^[26]

Rainbow pulse co-oximetry

Rainbow pulse co-oximetry uses multiple wavelengths of light to estimate several parameters noninvasively, including total hemoglobin (SpHb), carboxyhemoglobin (SpCO), and methemoglobin (SpMet), in addition to oxygen saturation (SpO₂), pulse rate, perfusion index (PI) and pleth variability index (PVI).^[27]

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.^[28][29][30] Studies in Emergency 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.^[31][32][33]

The Pronto-7 device for noninvasive spot-checking of hemoglobin, SpO₂ and pulse rate received a gold Medical Design Excellence Award,^[34] and the World Health Organization listed noninvasive hemoglobin testing among technologies relevant to global health needs.^[35]

Patient and consumer monitoring

Opioid-related monitoring and treatments

In June 2020, Masimo released Bridge, a neuromodulation device intended to reduce symptoms of opioid withdrawal.^[49]

In April 2023, the company received FDA De Novo clearance for a pulse-oximetry-based device designed to alert to respiratory depression as a potential early indicator of opioid overdose. The device was authorized for both prescription and over-the-counter distribution.^[50]

Smartwatches and wearables

In 2022, Masimo released the W1 smartwatch, 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.^[51]