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Masimo

Masimo Corporation is an American global medical technology company that develops, manufactures, and markets innovative noninvasive patient monitoring technologies, sensors, and automation platforms designed to improve patient outcomes and reduce the cost of care. In September 2025, Masimo completed the sale of its consumer audio business to , refocusing on healthcare solutions. Founded in 1989 by in a garage in , where it remains headquartered, Masimo has grown into a publicly traded entity on the stock exchange under the ticker symbol MASI, employing approximately 3,600 people worldwide as of December 2024. The company's core mission emphasizes advancing noninvasive monitoring to new applications and settings, including hospitals, , and home health, through proprietary technologies that enhance clinical decision-making and operational efficiency. Masimo's flagship innovations include its SET® Pulse Oximetry technology, which has been validated in over 100 independent studies for superior performance in measuring and pulse rate, particularly in challenging conditions such as patient motion and low . Building on this, the rainbow® SET® Pulse CO-Oximetry platform enables noninvasive measurement of additional parameters like total (SpHb®), , and , reducing the need for invasive blood draws. Key product lines encompass advanced monitors such as the Root® platform for integrated monitoring, portable devices like the Radical-7® and Radius VSM™, and spot-check tools including the Rad-67®, alongside solutions via the SafetyNet® platform. The company's technologies are widely adopted in leading healthcare institutions, with SET®-enabled devices used in the top 10 U.S. hospitals according to Newsweek's 2024-2025 Hospitals ranking. Masimo also prioritizes , offering a recycling program to minimize environmental impact, and continues to expand its portfolio through research-driven advancements in areas like and .

History

Founding and early development

Masimo was founded in 1989 by , an electrical engineer, in , as a garage startup dedicated to advancing noninvasive patient monitoring technologies. The company's initial focus was on improving to achieve reliable measurements in difficult clinical scenarios, particularly those involving patient motion and low blood perfusion, where conventional devices often underperformed. Traditional pulse oximeters at the time frequently failed in real-world hospital environments, generating excessive false alarms and inaccurate readings due to motion artifacts or poor peripheral perfusion, which compromised patient safety and clinician efficiency. Recognizing these shortcomings, Masimo's early research centered on developing innovative adaptive signal processing algorithms to extract accurate physiological signals from noisy data, forming the core of its proprietary Signal Extraction Technology (SET) for pulse oximetry. This approach aimed to enable continuous, reliable monitoring across diverse patient conditions without the limitations of earlier systems. During the , Masimo introduced its first SET-enabled devices, debuting the technology in 1995 to address motion and low-perfusion challenges. The company secured FDA 510(k) clearance for its products, including features for measure-through-motion performance by 1998, allowing initial market entry and adoption in clinical settings. Early commercial success came from selling these monitoring devices to hospitals, establishing a based on superior accuracy in noninvasive measurements. By 2007, Masimo had progressed to an on the Global Market under the MASI, raising to fuel ongoing while sustaining through hospital sales of its core oximetry solutions. This IPO represented a key transition from its startup origins to a established player in medical technology, setting the stage for expansions like Rainbow Pulse CO-Oximetry in subsequent years.

Key milestones, acquisitions, and divestitures

Masimo went public on August 8, 2007, with an on the that raised approximately $233 million, including the exercise of underwriters' over-allotment option. The net proceeds were allocated to support key growth initiatives, including $5 million for expansion to advance hardware, software, and clinical studies, and another $5 million for sales and marketing efforts to commercialize Masimo SET and Rainbow SET technologies, with a focus on expanding the sales force and international market presence. A significant product milestone came in 2014 with the introduction of the patient monitoring and connectivity platform, an expandable hub designed for integrated, multimodal monitoring that incorporated Masimo's foundational Signal Extraction Technology (SET) for enhanced accuracy in challenging conditions. This launch marked a shift toward modular, open-architecture systems, enabling third-party integrations via the Masimo Open Connect interface and supporting broader adoption in clinical settings. By 2015, Masimo had strengthened its international footprint, establishing direct sales and marketing operations across and to capitalize on growing demand for advanced monitoring solutions in these regions. In a strategic move to diversify beyond healthcare, Masimo acquired Sound United, a premium consumer audio company, for $1.05 billion in April 2022, gaining like , , and to accelerate its consumer product distribution. However, amid a refocus on core healthcare operations, Masimo divested the Sound United business to —a subsidiary—for $350 million, with the agreement announced in May 2025 and completed in September 2025. This transaction allowed Masimo to streamline resources toward professional monitoring innovations while generating proceeds for shareholder returns. The company's growth accelerated during the , reaching $1.14 billion in annual product revenue for 2020, a 22% increase from 2019, fueled by heightened global demand for and remote monitoring devices. This milestone underscored the scalability of Masimo's noninvasive technologies in crisis response, with international markets contributing significantly to the surge.

Leadership changes and recent corporate shifts

In September 2024, Masimo's founder and longtime CEO resigned following a contentious proxy battle with activist Politan Capital Management, which secured two board seats and led to Kiani's ouster as board chair during the annual . The conflict centered on disagreements over , strategic direction, and the performance of Masimo's consumer audio division, culminating in Kiani's departure alongside several other executives aligned with his vision. This marked a significant turning point, prompting an immediate leadership transition with board member Michelle Brennan appointed as interim CEO. By January 2025, Masimo announced the appointment of Katie Szyman, a veteran executive from Becton Dickinson and , as permanent CEO effective February 12, alongside a board expansion and restructuring to prioritize healthcare innovation and operational efficiency. Brennan transitioned to chairman, while Politan's nominees joined the board, shifting dynamics toward streamlined decision-making and a renewed emphasis on Masimo's core portfolio over diversified ventures. Under Szyman's , the company has focused on cost reductions, including workforce adjustments and strategic reviews, to enhance margins and redirect resources toward patient monitoring advancements. The leadership changes facilitated a corporate refocus in 2025, highlighted by the September completion of the Sound United consumer audio divestiture to for approximately $350 million, allowing Masimo to exit non-core operations acquired in 2022. This move, coupled with stock repurchases using sale proceeds, underscored a commitment to sustainable healthcare investments, as evidenced by third-quarter 2025 financial results showing revenue of $371.5 million—an 8.2% year-over-year increase—and trailing twelve-month revenue reaching $2.18 billion. The shift has influenced R&D priorities, with increased emphasis on advancing noninvasive technologies, including algorithms for detecting opioid-induced respiratory to support clinical interventions. Szyman's background in AI-enabled has steered investments toward innovations like the Opioid Halo® device for detecting , aligning with broader goals to improve in hospital and home settings. Full-year 2025 guidance projects healthcare revenue growth of 8-11%, reflecting this strategic pivot.

Core Technologies

Signal Extraction Technology (SET) pulse oximetry

Signal Extraction Technology (SET) represents Masimo's foundational innovation in noninvasive oxygen saturation monitoring, designed to overcome the limitations of conventional by accurately measuring arterial oxygen saturation (SpO₂) and pulse rate even in the presence of patient motion and low . At its core, SET applies adaptive signal processing techniques to separate the pulsatile signal from non-arterial noise sources, such as motion artifacts or pulsations, using ratios derived from red and through . This approach builds on the Beer-Lambert law, which describes as A = ε * c * l—where A is , ε is the , c is the concentration of the absorbing species (e.g., oxygenated or deoxygenated ), and l is the path length—enabling the estimation of oxygen saturation from differential at the two wavelengths. Developed in the by Masimo founder , SET specifically targeted the challenges of motion-induced artifacts and low-perfusion states, conditions that frequently rendered traditional oximeters unreliable in clinical settings like intensive units or during . Clinical trials conducted during this period demonstrated that SET achieved (ARMS) accuracy of 1.5% to 2% for SpO₂ measurements under motion and low-perfusion conditions, compared to the industry standard of 3% for conventional oximeters, representing a substantial improvement in reliability without invasive procedures. The U.S. (FDA) granted 510(k) clearance for SET in 1995, validating its performance for continuous monitoring in adult, pediatric, and neonatal patients. The mathematical foundation of SET involves computing the ratio of ratios (R) from photoplethysmographic signals: R = (AC_red / DC_red) / (AC_IR / DC_IR), where AC_red and AC_IR are the (pulsatile) components at red (approximately 660 nm) and (approximately 940 nm) wavelengths, respectively, and DC_red and DC_IR are the (steady-state) components. This ratio is then processed using a (DFT) to reject noise frequencies associated with motion or other interferences, isolating the arterial signal for precise SpO₂ calculation via empirical calibration curves. Parallel processing engines further enhance this by simultaneously analyzing multiple signal paths, ensuring robust performance across varying physiological conditions. Following its clearance, SET was integrated into portable devices such as the Masimo Rad-57 Pulse CO-Oximeter, which utilizes the technology for rapid SpO₂ assessments in () environments, where motion and low are common during patient transport or field care. Over 100 independent clinical studies have since corroborated SET's superior accuracy, establishing it as a standard for reliable in challenging scenarios.

Rainbow Pulse CO-Oximetry

Rainbow Pulse CO-Oximetry, introduced by Masimo in 2005, represents an advancement in noninvasive blood constituent monitoring by extending the company's pulse oximetry to utilize multiple wavelengths of light. Unlike traditional , which relies on two wavelengths to measure arterial (SpO₂), Rainbow employs seven or more wavelengths to simultaneously assess additional parameters such as (SpCO), (SpMet), and total hemoglobin (SpHb). This multi-wavelength approach builds on the foundational SET for handling motion and low , enabling broader clinical utility in challenging environments. The technology operates on an extension of the Beer-Lambert law, which relates light absorption to the concentration of absorbing species in a medium. In Rainbow Pulse CO-Oximetry, light attenuation data from multiple wavelengths are processed using matrix inversion techniques to solve simultaneous equations for the concentrations of various species, such as oxygenated (c_O₂), (c_CO), and (c_Met). This allows for the derivation of fractional saturations without requiring invasive sampling, providing real-time insights into dyshemoglobins that can mask standard SpO₂ readings. Clinical validations have demonstrated the accuracy and reliability of these measurements. The U.S. (FDA) cleared the first Rainbow-enabled device, the Rad-57 handheld monitor, in 2006 for noninvasive monitoring of SpCO and SpMet, facilitating early detection of and methemoglobin-related toxicities. In 2008, FDA clearance was granted for SpHb measurement, with studies confirming an accuracy of ±1 g/dL for total hemoglobin levels in the range of 6-18 g/dL, significantly reducing the frequency of invasive lab draws in and critical care settings. Independent research has further validated these parameters against laboratory CO-oximetry, showing low bias and high correlation even during motion or low . Integration of CO-Oximetry into portable devices like the Rad-57 and Pronto-7 supports spot-check assessments, particularly valuable for rapid screening in scenarios such as suspected , where elevated SpCO levels can be identified noninvasively to guide timely interventions. These devices display plethysmographic waveforms alongside numerical readouts, aiding clinicians in evaluating signal quality. At its core, processes plethysmographic waveforms captured by the , applying advanced signal to isolate arterial pulsatile components from venous and tissue noise across all wavelengths. This includes adaptive filtering techniques for artifact removal, ensuring robust performance in dynamic conditions, though specific implementations like enhancements are proprietary and evolve with ongoing refinements.

Advanced proprietary innovations

Masimo's advanced proprietary innovations extend the capabilities of its foundational multi-parameter sensing technologies by incorporating (NIRS) for cerebral tissue oxygenation and AI-enhanced integration platforms for real-time data analysis and connectivity. The ORi (Oxygen Reserve Index) system, introduced in 2014 with as the 11th Rainbow parameter, employs NIRS to noninvasively and continuously monitor cerebral oxygenation, providing an index that indicates moderate (PaO2 between 100 and 200 mmHg) when supplemental oxygen is administered. This technology measures brain tissue (StO2) to offer resolution beyond standard (SpO2), helping clinicians detect and manage elevated oxygen levels during procedures. In 2023, ORi received U.S. FDA clearance as the first continuous, noninvasive parameter for this purpose, specifically for adults and transitional adolescents (18 years and older) undergoing in settings. Complementing ORi, Masimo's O3 Regional Oximetry, cleared by the FDA in 2016 for cerebral applications, uses NIRS to measure regional (rSO2, equivalent to StO2) in tissue across all patient populations, including neonates, , , and adults. The system achieved expanded FDA clearance in 2019 for neonatal and patients under 10 kg, with a trending accuracy of 3% A_RMS, enabling monitoring of cerebral desaturation events in vulnerable groups. Further expansions in 2020 and 2025 included applications and delta hemoglobin parameters for both cerebral and tissues, supporting absolute accuracy of 4% A_RMS in adults and 3% A_RMS trending across populations. In the realm of integration platforms, the , launched in the and evolved through the , serves as an expandable connectivity hub that aggregates data from Masimo and third-party devices for parameter trending and . It facilitates AI-driven workflows by automating data transfer to electronic medical records (EMRs) and patient data management systems (PDMS), reducing manual entry and enabling customizable views of waveforms, trends, and alerts. Similarly, the platform, introduced in the late , provides cloud-based analytics for alarm management and , integrating data from connected devices to generate trend graphs, histograms, and actionable insights on events like desaturations. In 2025, Masimo updated its Hospital Automation platform, incorporating Root and Iris with enhanced cloud-based distributed architecture for scalable data processing and remote access, improving efficiency in parameter trending across care settings. Masimo's R&D efforts include solutions like SafetyNet, a cloud-based telemonitoring system designed to support remote patient monitoring.

Healthcare Monitoring Solutions

Patient safety and remote monitoring systems

Masimo's Patient SafetyNet, launched in 2008, is a remote monitoring and wireless clinician notification system designed for continuous surveillance of vital signs in hospital settings, particularly focusing on parameters like oxygen saturation (SpO2) to enable early detection of deteriorations. The system integrates with bedside monitors to transmit data wirelessly to a central station, where customizable alerts notify clinicians via pagers or other devices when thresholds, such as SpO2 drops, are breached, allowing for timely interventions without constant bedside presence. Clinical studies have demonstrated its effectiveness in reducing alarm fatigue; for instance, implementation of Patient SafetyNet with Masimo SET pulse oximetry has been associated with over 50% reductions in false alarms compared to conventional systems in postoperative care units. Complementing SafetyNet, the Radius-7, a tetherless wearable cleared by the FDA in 2014, supports ambulatory patient monitoring by providing portable, continuous tracking of including SpO2, pulse rate, and perfusion index using Masimo SET technology for reliable performance in motion. Each Radius-7 unit features hot-swappable modules, delivering up to 12 hours of runtime per module to facilitate extended use with minimal interruptions, typically requiring only one exchange per shift. Integrated with central systems like SafetyNet, it enables seamless flow for general floor patients, reducing the need for wired connections and enhancing mobility while maintaining alert capabilities for critical events. In hospital deployments, Patient SafetyNet and Radius-7 have been integrated with electronic medical record (EMR) systems such as , with the first such integration occurring in 2014 at North Oaks Medical Center, enabling automated data transfer and improved workflow efficiency. By 2025, expansions in capabilities post-COVID have accelerated, including a renewed strategic partnership with announced in September to enhance connectivity across bedside and remote monitoring platforms, and deployments like University Hospitals' rollout to 1,500 beds in for continuous tracking. These systems have been adopted in hundreds of facilities worldwide, with Masimo SET technology estimated to monitor over 200 million patients annually in leading hospitals. Clinical evidence underscores the impact on , with studies showing early detection of deteriorations leading to reduced response times; for example, prior studies, including one in a smaller referenced in a 2025 analysis, reported a 65% reduction in rapid response team activations and a 48% reduction in transfers to the ICU following SafetyNet implementation. In another before-and-after study in a 1,200-bed facility, the system contributed to significant drops in CPR events and improved success rates, alongside shorter hospital lengths of stay. These outcomes highlight how such remote monitoring reduces unplanned transfers and enhances overall efficiency in general care .

Brain function and acoustic monitoring

Masimo's SedLine brain function monitoring system, acquired in 2010 through the purchase of SEDLine Inc., utilizes a four-channel processed electroencephalogram (EEG) to assess the depth of in surgical patients. This technology processes bilateral EEG signals from the frontal to generate the Patient State Index (), a numerical indicator ranging from 0 to 100 that reflects the patient's level of , with lower values indicating deeper . Complementing the , the system includes a Density Spectral Array () visualization, which displays time-varying EEG power spectra in a color-coded format to help clinicians identify patterns such as —periods of high-amplitude EEG activity alternating with isoelectric intervals that signal excessive anesthetic depth. These features enable real-time monitoring of brain function during , aiding in the of anesthetics to maintain optimal while minimizing risks like intraoperative . In 2018, Masimo received FDA clearance for the Next Generation SedLine, which enhances the original system by integrating with O3 regional oximetry for simultaneous assessment of cerebral oxygenation and EEG activity on the Root patient monitoring platform. This advancement provides a more comprehensive view of cerebral and oxygenation, particularly useful in procedures involving or where is a concern. The system processes EEG data to detect asymmetries between hemispheres, alerting clinicians to potential neurological compromise. In critical care settings like the (ICU), SedLine supports ongoing evaluation of sedation levels in mechanically ventilated patients, helping to balance comfort and neurological protection. Introduced in 2013, Masimo's Acoustic Monitoring () offers a noninvasive method for measuring respiration rate through an adhesive placed on the neck or chest, which captures tracheal sounds and converts them into respiratory cycles using acoustic . Validated against , demonstrates accuracy within ±1 breath per minute across a range of 4 to 70 breaths per minute in adult and pediatric patients, providing reliable tracking during and post-operative recovery. This technology integrates with Masimo's platform for multi-parameter monitoring, enhancing detection of respiratory depression without invasive airways. In and ICU environments, facilitates early identification of , supporting timely interventions in sedated or opioid-administered patients. Recent advancements, including a 2025 clinical study, highlight SedLine's benefits in pediatric , where it contributed to safer dosing of inhalational agents and reduced procedural times in children undergoing . For acoustic monitoring, pediatric applications were expanded with FDA clearance in 2018 for neonatal sensors, enabling precise respiration rate measurement in infants weighing under 10 kg during critical care. These tools collectively address neurological and respiratory monitoring needs in vulnerable populations, prioritizing in high-acuity settings.

Respiratory, gas, and opioid monitoring

Masimo's solutions include the Integrated Sidestream Analyzer (), introduced in 2017 as an integrated module for devices like the Rad-97 pulse CO-oximeter, enabling sidestream monitoring of end-tidal (EtCO₂), oxygen (O₂), (N₂O), and anesthetic agents. The uses with multiple wavelengths to achieve measurements across ranges such as 0–150 mmHg for EtCO₂ and FiCO₂, with accuracy of ±0.2 vol% for CO₂ in the 0–15 vol% range under standard conditions, and similar precision for O₂ (±2 vol%) and N₂O (±2 vol%). Sidestream technology samples gas via NomoLine sampling lines at 50 ml/min without removing gas from the , offering flexibility for intubated and non-intubated patients, while Masimo's mainstream option, such as the IRMA analyzer, provides in-line measurements with reduced delay for faster response in settings. In respiratory rate monitoring, Masimo's Respiration Rate from the Pleth (RRp®) technology, cleared by the FDA for continuous use in 2020, derives respiration rate noninvasively from the photoplethysmographic waveform obtained via sensors, providing automated trending without additional hardware. This approach integrates with Masimo SET® pulse oximetry to deliver respiration rates with accuracy comparable to manual counts, particularly in pediatric and adult patients, helping clinicians detect respiratory compromise early in and critical care environments. Acoustic respiration rate complements such methods by capturing airway sounds, though detailed acoustic applications are addressed elsewhere. For opioid monitoring, Masimo's Opioid ™ system, granted FDA authorization in 2023, represents the first over-the-counter wearable for detecting -induced respiratory depression through continuous tracking of peripheral (SpO₂), pulse , and , issuing escalating alarms if desaturation or occurs. The device targets at-risk individuals, including those prescribed for , by identifying physiological markers of overdose such as SpO₂ below 80% or under 6 breaths per minute. A 2025 qualitative study on a shoulder-mounted wearable prototype for detecting overdoses, which references technologies like Masimo , explored user preferences including alerts to in scenarios involving synthetic such as . This integration supports rapid intervention in pre-hospital settings, aligning with broader efforts to mitigate the crisis.

Consumer and Wearable Products

Smartwatches and fitness trackers

Masimo entered the consumer wearables market in 2022 with the launch of the smartwatch, marking its first foray into lifestyle-friendly devices that adapt core medical technologies for everyday health tracking. The , initially released in a limited market edition in May 2022 and fully available by August, featured continuous monitoring of (SpO2) using Masimo's Signal Extraction Technology (SET), alongside () measurements, making it suitable for users seeking reliable data during daily activities. In July 2024, Masimo introduced Sleep Halo software for the , enabling advanced analysis through over 70,000 daily measurements and to generate sleep scores and insights into quality and duration. The device received FDA 510(k) clearance in November 2023 as the first approved for continuous, SpO2 and tracking in both over-the-counter and prescription settings, establishing medical-grade accuracy for use. In 2023, Masimo announced the Freedom platform, intended to expand its wearable lineup with a smartwatch and band-style tracker designed for seamless all-day monitoring without the bulk of a full smartwatch. The planned Freedom Band was to pair with the Freedom smartwatch or operate independently via the Masimo Health app, allowing users to alternate wear for 24/7 coverage of metrics like SpO2, heart rate, respiration rate, hydration index, and activity steps, with data synchronization for trend analysis and personalized wellness guidance. This modular approach was to emphasize uninterrupted tracking during sleep, exercise, or charging, integrating Bluetooth, Wi-Fi, and LTE for app-based alerts and sharing. However, the Freedom platform was never commercially launched. In 2025, following the sale of its audio business, Masimo discontinued all wearable products, including the , to refocus on professional healthcare innovations. Strategic partnerships continued in healthcare monitoring, including a September 2025 collaboration with to incorporate AI-driven sensor integration for advanced patient monitoring solutions, and an ongoing alliance with announced in September 2024 to develop reference platforms with premium health features like improved detection. These efforts shifted toward broader ecosystem compatibility in professional settings. Masimo's discontinued wearables had differentiated from competitors like by leveraging SET pulse oximetry, which maintains accuracy during low-perfusion conditions—such as cold extremities or motion—where studies show errors as low as 1.37% compared to less validated trackers. This clinical edge, validated in over 100 independent studies, underscored Masimo's focus on reliable readings across diverse skin tones and physiological states.

Historical expansion into consumer audio

In 2022, Masimo expanded beyond its core healthcare monitoring technologies by acquiring Sound United, a leading developer of premium consumer audio products, for $1.025 billion. This acquisition brought iconic brands such as , , , and under Masimo's umbrella, with the strategic intent to integrate advanced audio expertise into wearable health devices and create synergies between entertainment and patient monitoring ecosystems. Sound United was rebranded as Masimo Consumer Audio in early 2023, operating as a dedicated division to drive innovation in high-performance sound solutions. The expansion introduced products that blended audio capabilities with elements of health-oriented personalization. A key launch was the PerL true wireless earbuds in June 2023, which incorporated Masimo Adaptive Acoustic Technology (AAT) to create individualized sound profiles based on users' otoacoustic emissions, enhancing audio depth and detail tailored to hearing sensitivity. This was complemented by expansions into , speakers, and home integration systems, including the HEOS platform's connectivity to Masimo's cloud-based health monitoring for seamless between audio devices and wearables. These offerings aimed to position Masimo in the growing personalized hearables market while leveraging audio hardware to support non-invasive health tracking features. Despite initial ambitions, the venture encountered significant hurdles, including operational integration complexities and a perceived dilution of focus from Masimo's medical technology strengths, amid broader market pressures in consumer electronics. These challenges culminated in a $304 million impairment charge on Sound United goodwill and intangibles in fiscal 2024, reflecting underperformance relative to expectations. In May 2025, Masimo announced the sale of its consumer audio business to HARMAN International, a subsidiary of Samsung Electronics, for $350 million, with the transaction closing in September 2025. The audio segment reached a revenue peak of $699.1 million in full-year 2024, representing non-healthcare sales that grew 11% in the fourth quarter alone but declined 9-10% overall for the year on a constant currency basis. The divestiture allowed Masimo to streamline operations, eliminate the non-healthcare reporting segment, and redirect resources toward its primary medtech innovations, ultimately boosting margins and enabling share repurchases.

Legal and Regulatory Issues

Patent disputes and intellectual property battles

Masimo's most prominent intellectual property conflict has been with , stemming from initial collaboration discussions in 2013. During those meetings, Masimo executives shared details of their technology, including Signal Extraction Technology (SET), with Apple representatives exploring potential partnerships for health monitoring features in wearables. Masimo later alleged that Apple misappropriated this information to develop its own oxygen sensing capabilities, leading to a formal filed on January 9, 2020, in the U.S. District Court for the Central District of . The suit claimed infringement of nine Masimo patents related to low-power , , and elements used in Series 4 and later models. In parallel, Masimo pursued a complaint with the U.S. International Trade Commission () in 2020, asserting that Apple's imports violated Section 337 of the Tariff Act by infringing five key patents on noninvasive oxygen measurement. The ITC investigation culminated in a significant ruling on October 25, 2023, finding that infringed Masimo's patents for light-based technology, resulting in a limited exclusion order banning the import and sale of infringing models (Series 9 and Ultra 2) in the United States. This decision led to a temporary halt in U.S. sales of the affected models starting January 18, 2024, after the Federal Circuit denied Apple's appeal to stay the ban. responded by redesigning the devices to disable the blood oxygen feature via software, which allowed sales to resume under a temporary approved by U.S. and (CBP). However, the dispute escalated in 2025, with ongoing negotiations where Masimo has offered licensing terms for its patents, though no agreement has been reached. In August 2025, Masimo sued CBP, challenging an ruling that permitted to restore the function through a modified algorithm, claiming it still infringed Masimo's . On November 14, 2025, a federal jury found liable for infringing Masimo's Patent No. 10,433,776 related to workout mode and notifications, awarding Masimo $634 million in damages. As of November 15, 2025, the is considering a new import ban on updated models. Beyond the Apple litigation, Masimo has enforced its against other competitors, securing notable victories in and related technologies. In 2015, Masimo resolved a multi-year dispute with Medical by obtaining a $25 million settlement and assignment of certain patents, addressing allegations of infringement on Masimo's SET innovations. Masimo holds over 1,000 granted patents globally, spanning noninvasive monitoring, , and multi-wavelength co-oximetry under its Rainbow platform, which have been central to these defenses. These efforts, including a 2022 federal court ruling in Masimo's favor against True Wearables for infringing wireless patents, underscore the company's aggressive IP strategy. The cumulative impact of these battles has strengthened Masimo's position in the wearable health monitoring market, enabling it to launch its own devices like the and smartwatches while deterring unauthorized use of its core technologies. By leveraging remedies and licensing discussions, Masimo has not only protected its innovations but also expanded its influence in and wearables amid ongoing regulatory and competitive pressures.

Product accuracy controversies and regulatory scrutiny

During the from 2020 to 2022, pulse oximeters, including those from Masimo, faced heightened scrutiny for accuracy issues in patients with darker skin tones, where devices often overestimated arterial (SpO2) compared to actual oxygen levels (SaO2), leading to underestimation of severity by an average of 3% and up to 12% in some cases. The U.S. (FDA) issued public communications in 2021 and 2022 highlighting these racial biases, noting that such inaccuracies could delay critical interventions for and patients, who experienced up to three times higher rates of undetected low oxygen levels during the crisis. While the FDA's warnings were industry-wide, they amplified concerns about Masimo's devices, prompting calls for improved testing protocols across diverse populations. In response, Masimo conducted clinical trials between 2021 and 2023 to validate its pulse oximetry in diverse skin tones, with peer-reviewed studies demonstrating no clinically significant bias or accuracy differences between Black and White subjects, even under low perfusion conditions, achieving accuracy within FDA limits of ±2-3%. These efforts led to FDA 510(k) clearances in 2024 for products like the MightySat Medical fingertip oximeter and W1 wearable, incorporating expanded validation data on skin pigmentation to address prior limitations. The FDA's 2024 on pulse oximeter performance further referenced Masimo SET as exhibiting low bias across tones, supporting re-clearances amid broader regulatory pushes for equitable device testing. By 2025, regulatory attention shifted to ongoing compliance and post-market surveillance, including the FDA's draft guidance mandating diverse skin tone testing in premarket submissions and enhanced labeling for accuracy limitations in all pulse oximeters. Masimo's Rainbow multi-parameter devices, which extend beyond standard pulse oximetry to measure parameters like carboxyhemoglobin, underwent continued EU Medical Device Regulation (MDR) audits for certification, with the company reporting successful CE marks for related modules like LiDCO while navigating MDR's stringent clinical evaluation requirements. These efforts culminated in enhanced product labeling to disclose performance variability by skin tone, aiming to mitigate risks identified in earlier controversies.

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