U.S. Pulse Oximeters Market Size, Share & Industry Analysis, By Product Type (Fingertip Oximeters, Handheld Oximeters, Tabletop Oximeters, and Others), By Technology (Conventional and Smart), By Age Group (Adults and Pediatrics), By Area of Care (Hospitals/Acute Care [ICU, Operating Rooms & Post-Anesthesia Care Units, and Emergency Departments), Ambulatory & Outpatient Care [Primary Care Clinics, and Specialty Clinics], Homecare/Remote Monitoring [Chronic Disease Management, Post-discharge Monitoring, Telehealth/Remote Patient Monitoring Platforms], and Others), and Country Forecast, 2025-2032

The U.S. pulse oximeters market size was valued at USD 506.8 million in 2024. The market is projected to grow from USD 515.8 million in 2025 to USD 700.2 million by 2032, exhibiting a CAGR of 4.5% during the forecast period.

Pulse oximeters refare electronic devices that measures the oxygen saturation and pulse rate. The rising prevalence of chronic respiratory diseases such as chronic obstructive pulmonary disorder (COPD), asthma, and others is resulting in a growing number of patient admissions, further supporting the demand for pulse oximeter products in the market. Additionally, a growing geriatric population is a major contributing factor, which is further increasing the prevalence of respiratory conditions all over the globe. Increasing prevalence and patient admissions, coupled with technological advancements are resulting in growing demand for these devices, thereby fueling the adoption rate in the U.S.

Furthermore, the market encompasses several prominent players, including Masimo, Medtronic, GE Healthcare, Koninklijke Philips N.V., and others. Robust and diversified product portfolio with novel product launches and significant focus towards acquisitions and mergers among the other players is responsible for their increasing market share.          

MARKET DYNAMICS

MARKET DRIVERS

Increasing Prevalence of Chronic Respiratory Diseases to Drive the Market Growth

There is an increasing prevalence of chronic respiratory diseases, including asthma, chronic obstructive pulmonary disease (COPD), lung cancer, cystic fibrosis, sleep apnea, and occupational lung diseases among the patient population in the U.S.

• For instance, according to 2024 statistics published by the Centers for Disease Control and Prevention (CDC), around 8.6% of adults aged 18 and above have asthma in the U.S.

Additionally, these respiratory conditions account for a significant proportion of global morbidity and mortality, resulting in an increasing need for continuous, real-time monitoring of blood oxygen saturation (SpO2) and pulse rate among the patient population. Pulse oximetry solutions have become an important tool for early detection of hypoxemia and monitoring disease progression, particularly in patients with chronic respiratory conditions.

With the rising prevalence of CHDs, COPD, and other respiratory diseases in infants and the geriatric population, the demand for technologically advanced products is increasing. Therefore, the increasing prevalence of chronic respiratory diseases requiring pulse oximetry solutions and the growing focus of companies to increase the production capacity are expected to drive the U.S. pulse oximeters market growth.

MARKET RESTRAINTS

Presence of Alternative Productsto Limit the Market Growth

The growing prevalence of chronic respiratory conditions has also increased the adoption of various patient monitoring devices, including vital sign monitoring systems and smartphone applications, hampering the demand and usage of pulse oximeters in the market.

The adoption of integrated vital sign monitoring systems and smartphone applications is increasing due to their comparatively lower cost and easy availability. The rising preference for integrated systems by the healthcare provider and customers is due to the ease of monitoring vital signs at a single location, among other clinical benefits.

The increasing investment by prominent players in developing integrated vital sign monitoring systems is one of the key elements expected to increase their adoption in hospitals, clinics, ASCs, and others.

• For instance, in July 2024, Huntleigh, a member of the Arjo family, launched its new SC500 Series vital signs monitor, which provides high-performance monitoring of various parameters such as non-invasive blood pressure, pulse rate, pulse oximetry, and others among the patient population.

MARKET OPPORTUNITIES

Increasing Number of Partnerships & Acquisitions To Augment the Demand for Products

There is an increasing prevalence of chronic disorders resulting in a growing number of patient admissions in hospitals and other healthcare settings. A growing number of patient admissions, coupled with an increasing number of healthcare facilities, is expected to boost the demand for these devices.

In order to cater to this growing demand, key players are focusing on partnerships and acquisitions among other players in the industry. The growing number of acquisitions and partnerships among the key players and digital health platforms, sensor technology companies, and medical device firms is creating lucrative opportunities by enabling the integration of pulse oximetry into remote patient monitoring systems and health solutions, thereby contributing to the market growth.

• In May 2025, GE Healthcare partnered with Raydiant Oximetry, Inc., to accelerate innovation in fetal saturation monitoring technology. The companies plan to co-develop a product that supports the incorporation of Raydiant Oximetry’s fetal pulse oximetry technology into GE HealthCare’s fetal monitoring and digital perinatal surveillance platforms.

U.S. PULSE OXIMETERS MARKET TRENDS

Growing Adoption of Pulse Oximetry Solutions in Homecare Settings

In recent years, pulse oximeters have been increasingly used in home care settings owing to increasing benefits such as easy detection of hypoxemia, continuous monitoring of blood oxygen levels, and others. Thus, demand for these devices is rapidly growing among the end users, further resulting in growing focus among prominent players on developing and launching pulse oximetry solutions for home care settings. Furthermore, adequate reimbursement policies and expansion of remote patient monitoring solutions are leading healthcare providers to prescribe clinical-grade pulse oximetry solutions for use at home.

• In December 2024, Nonin Medical received U.S. FDA approval for its first over-the-counter (OTC) FDA-cleared fingertip pulse oximeter, the TruO2 OTC, with an aim to offer cutting-edge medical device technology to consumers and healthcare professionals.

MARKET CHALLENGES

Regulatory & Compliance Barriers to Limit Market Growth

One of the crucial factors challenging the market growth is the regulatory and compliance barriers for these devices. The manufacturers are expected to meet safety, reliability, and accuracy through the De Novo pathways, which are time-consuming and costly. Recently, the FDA issued draft guidelines stating enhanced surveillance of clinical validation protocols to improve the performance and accuracy across individuals with darker skin tones, standardized skin tone measurement, among others.

• For instance, according to 2022 statistics published by Arrotek, about 32% of FDA 510(k) medical device submissions failed their first acceptance for review check.

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Segmentation Analysis

By Product Type

Increasing Prevalence of Respiratory Conditions Contributed to the Tabletop Oximeters Segmental Growth

Amongst product types, the market is segmented into fingertip oximeters, handheld oximeters, tabletop oximeters, and others.

The tabletop oximeters segment accounted for a significant U.S. market share in 2024. The segment's growth is owing to the increasing prevalence of respiratory diseases, resulting in a growing number of patient admissions in healthcare settings such as hospitals and others. Tabletop oximeters are mainly used in the highest-value clinical settings owing to their benefits, such as high accuracy and continuous blood glucose monitoring, among others. Along with this, the regulatory scenario and reimbursement policies also emphasize clinical-grade devices for hospital use, further supporting the adoption rate for these products in the market.

• For instance, according to 2025 statistics published by the American Cancer Society, it was estimated that about 226,650 new lung cancer cases are expected to be diagnosed in the U.S.

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By Technology

Increasing Adoption Rate Drives Growth of Conventional Segment

In terms of technology, the market is divided into conventional and smart.

The conventional segment captured the largest U.S. pulse oximeters market share in 2024. In 2025, the segment is anticipated to dominate with a 62.2% share. The segmental growth is due to the various factors, including rising installed bases for conventional devices, widespread adoption of conventional systems in healthcare facilities such as intensive care units, operating rooms, post-anesthesia care units, and wards, and less stringent regulatory and reimbursement scenarios, among others.

• For instance, according to a 2024 study published by Science Direct, it was reported that about 88.8% inpatient days included the use of conventional pulse oximetry monitoring in the U.S.

The smart segment is expected to grow at a CAGR of 4.7% during the forecast period.  

By Age Group

Increasing Prevalence of Respiratory Conditions Among Adults to Drive Segment Growth

Based on age group, the market is segmented into adults and pediatrics.

The adults segment held the dominating position in 2024. By age group, the adults segment held the share of 88.7% in 2024. The growing burden of respiratory diseases such as chronic obstructive pulmonary disease (COPD), asthma, and others among the adult population in the U.S. is resulting in growing demand for pulse oximetry solutions, thereby driving the focus of key players towards R&D activities to develop and introduce novel devices in the market.

• For instance, according to 2024 statistics published by the National Heart, Lung, and Blood Institute, it was reported that about 14.0 million adults are suffering from chronic obstructive pulmonary disease in the U.S.

The segment of pediatrics is set to flourish with a growth rate of 3.6% growth across the forecast period.

By Area of Care

Increasing Number of HospitalsAcute Care Settings Led to the Segmental Dominance

Based on the area of care, the market is classified into hospitals/acute care, ambulatory & outpatient care, home care/remote monitoring, and prehospital/EMS ambulance services. The hospitals/acute care segment is further divided into ICU, operating rooms & post-anesthesia care units, and emergency departments. The ambulatory & outpatient care segment is sub-classified into primary care clinics and specialty clinics. The home care/ remote monitoring is divided into chronic disease management, post-discharge monitoring, and telehealth/remote patient monitoring platforms.

The growth is due to the increasing incidence of respiratory and other conditions is resulting in a rising number of hospital admissions requiring continuous patient monitoring in the country. This, along with a growing number of hospitals, is further expected to boost the adoption rate for pulse oximetry solutions, thereby contributing to the growth of the segment. Furthermore, the segment is set to hold a 43.2% share in 2025.

• For instance, according to the statistics published by the American Hospital Association (AHA) in the U.S., there are about 6,093 hospitals in the U.S.

In addition, home care/remote monitoring end users are projected to grow at a CAGR of 5.0% during the study period.

COMPETITIVE LANDSCAPE

Key Industry Players

Increasing Number of Product Offerings Among Prominent Players Supported Their Dominance

The U.S. market shows a semi-consolidated structure with numerous small-to-mid-sized players actively operating in the industry.

Masimo dominated the U.S. market in 2024. The significant focus of the company on the integration of pulse oximetry technology into its products is one of the major reasons supporting the growth of the company in the market.

• In August 2024, Masimo received U.S. Food and Drug Administration approval for the Masimo W1 medical watch integrated with MasimoSafetyNet comprehensive telemonitoring solution, with an aim to strengthen its product portfolio.

Apart from this, other prominent players in the market include Medtronic, GE Healthcare, Koninklijke Philips N.V., and others. These companies are focusing on various inorganic growth strategies, including investments in R&D and collaborations to strengthen the brand presence for players in the U.S. pulse oximeters market.

LIST OF KEY U.S. PULSE OXIMETERS COMPANIES PROFILED

• GE Healthcare (U.S.)
• Masimo (U.S.)
• Drägerwerk AG & Co. KGaA (Germany)
• Nonin (U.S.)
• Medtronic (Ireland)
• Koninklijke Philips N.V. (Netherlands)
• ICU Medical, Inc. (U.S.)
• Beurer GmbH (Germany)
• NIHON KOHDEN CORPORATION (Japan)
• OMRON Corporation (Japan)

KEY INDUSTRY DEVELOPMENTS

• August 2025: Drägerwerk AG & Co. KGaA received the company’s Authority to Operate (ATO) certification for the Atlan A350/A350 XL series of anesthesia workstations, which provides the highest level of patient data security for medical devices. This helped the company in strengthening its brand presence.
• August 2024: Masimo received U.S. Food and Drug Administration approval for the Masimo W1 medical watch integrated with the MasimoSafetyNet comprehensive telemonitoring solution, with an aim to strengthen its product portfolio.
• May 2024: Masimo received U.S. FDA approval for the Stork Over-the-Counter (OTC) baby monitoring system that utilizes pulse-oximetry technology with an aim to widen its product portfolio.
• December 2024: Nonin received U.S. FDA approval for its first over-the-counter (OTC) FDA-cleared fingertip pulse oximeter, the TruO2 OTC, with an aim to strengthen its product offerings.
• February 2021: Medtronic announced the results of a prospective observational study comparing the efficacy and reliability of two pulse oximeters — Nellcor Bedside SpO2 Patient Monitoring System and Masimo Radical-7 Pulse Co-Oximeter. This helped the company in strengthening its presence.

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