North America Pulse Oximeter Market

North America Pulse Oximeter Market Size

The North America pulse oximeter market size was valued at USD 0.92 billion in 2024 and is estimated to reach USD 1.80 billion by 2033 from USD 0.99 billion in 2025, registering a CAGR of 7.69% from 2025 to 2033.

Pulse oximeters are non-invasive medical devices designed to measure oxygen saturation levels in the blood, providing critical insights into respiratory and cardiovascular health. These compact devices have become indispensable in both clinical settings and home healthcare, especially amid rising awareness of chronic conditions such as COPD, asthma, and heart disease. The North America pulse oximeter market is currently witnessing robust growth, driven by advancements in sensor technology, increasing prevalence of respiratory ailments, and a growing emphasis on preventive healthcare. Hospitals, clinics, and ambulatory surgical centers remain the primary users, but the demand for wearable and portable pulse oximeters has surged among consumers seeking real-time health monitoring.

The COVID-19 pandemic acted as a catalyst for this market, with widespread adoption of pulse oximeters to monitor silent hypoxia a condition where oxygen levels drop dangerously without obvious symptoms. According to the Centers for Disease Control and Prevention, approximately 20% of COVID-19 patients experienced this phenomenon, prompting a surge in household purchases. Beyond the pandemic, data from the American Lung Association states that over 37 million Americans live with chronic lung diseases, further fueling the need for accessible diagnostic tools like pulse oximeters.

Interestingly, a study published by the National Center for Health Statistics reveals that nearly 45% of U.S. adults now track at least one health metric regularly, showcasing a cultural shift toward proactive health management. Additionally, a report by the World Health Organization underscores that non-communicable diseases account for 74% of all deaths in the Americas, emphasizing the role of devices like pulse oximeters in managing these conditions. This confluence of technological innovation, public health trends, and consumer behavior sets the stage for sustained growth in the pulse oximeter market across North America.

MARKET DRIVERS

AI Integration Elevates Pulse Oximeter Capabilities

Artificial intelligence is revolutionizing pulse oximeters, making them smarter and more effective. These AI-powered devices can track oxygen levels over time and identify patterns that may signal potential health issues before symptoms arise. According to Accenture, the AI healthcare trade is expected to hit a major mark by 2026, with diagnostic tools playing a key role. For instance, AI-enhanced pulse oximeters can spot irregularities like abnormal breathing or dropping oxygen levels, alerting users and doctors early. Research from the Journal of Medical Internet Research shows that such innovations reduce hospital readmissions by up to 30%. By combining cutting-edge technology with personalized care, these devices are gaining traction in North America, driving demand across diverse user groups.

Workplace Health Boosts Pulse Oximeter Demand

Pulse oximeters are becoming essential tools for ensuring employee health and safety, especially in high-risk industries. The Occupational Safety and Health Administration estimates that over 5 million U.S. workers are exposed to hazardous air conditions each year. In sectors like mining and manufacturing, these devices help monitor oxygen levels in real-time, safeguarding workers' well-being. A report from the National Institute for Occupational Safety and Health shows that companies investing in health technologies see a 25% drop in work-related illnesses. With remote work on the rise, portable pulse oximeters are also being used by employees managing health conditions at home. By targeting workplace wellness programs, manufacturers can tap into this growing demand and expand their reach.

MARKET RESTRAINTS

Accuracy Issues Undermine Trust in Certain Groups

A significant hurdle for the pulse oximeter market is the device's reduced accuracy in individuals with darker skin tones. Research published in the New England Journal of Medicine reveals that these devices overestimate oxygen levels in Black patients by an average of 3% compared to white patients. This discrepancy can delay critical medical interventions, particularly for minority communities already facing higher rates of respiratory issues. The American Thoracic Society emphasizes that such inaccuracies erode trust in the technology. Manufacturers must recalibrate their devices to ensure they perform reliably across all demographics. Until this problem is resolved, it remains a barrier to widespread adoption and undermines efforts to make healthcare more inclusive.

Supply Chain Woes Hinder Production

Supply chain disruptions and shortages of key components are hampering the production of pulse oximeters in North America. The global semiconductor shortage has hit the medical device industry hard, with lead times for essential parts rising by 50% in 2022, according to the Semiconductor Industry Association. Geopolitical tensions and trade restrictions have further complicated access to raw materials. McKinsey & Company estimates that supply chain issues cost the healthcare sector $183 billion annually in lost revenue. For pulse oximeter makers, these challenges translate into higher costs and delays, making it harder to meet growing demand. Addressing these bottlenecks is crucial to maintaining steady production and market growth.

MARKET OPPORTUNITIES

Pediatric Applications Open New Doors

Expanding pulse oximeter use in pediatric care presents a promising opportunity. Conditions like congenital heart defects and asthma require precise oxygen monitoring, yet many children lack access to suitable devices. The Centers for Disease Control and Prevention reports that congenital heart defects affect about 1% of births in the U.S. each year. A study by the Pediatric Academic Societies shows that detecting low oxygen levels early can cut mortality rates by 20%. Tailoring devices for children’s unique needs such as smaller sensors and kid-friendly designs can address this gap. By partnering with pediatric hospitals and researchers, manufacturers can develop innovative solutions that cater to this underserved population, unlocking new growth avenues.

Sustainability Drives Innovation

The shift toward eco-friendly products offers a fresh opportunity for the pulse oximeter market. Growing environmental concerns are prompting consumers and healthcare providers to seek sustainable options. The Environmental Protection Agency notes that e-waste makes up 2% of landfill waste in the U.S., with medical devices contributing significantly. Manufacturers adopting green practices, like using recyclable materials or designing energy-efficient models, can stand out in the market. Nielsen research shows that 73% of North American consumers are willing to pay more for sustainable products. By focusing on eco-conscious designs and packaging, companies can appeal to environmentally aware buyers while meeting regulatory standards. This approach not only boosts brand loyalty but also supports broader sustainability goals.

MARKET CHALLENGES

Reluctance to Embrace New Technology

Resistance to adopting advanced pulse oximeters is a challenge, especially among traditional healthcare providers and long-time users. The American Hospital Association reports that over 40% of healthcare professionals hesitate to switch to digital or AI-enabled devices due to perceived complexity or insufficient training. Older models remain popular in rural clinics and small facilities, where simplicity is valued over innovation. A study by the Healthcare Information and Management Systems Society identifies resistance to change as a top barrier to implementing new technologies. This reluctance slows the adoption of features like cloud connectivity and predictive analytics, limiting market growth. Simplifying designs and offering robust training programs can help bridge the gap between old habits and new possibilities.

Reimbursement Gaps Limit Home Use Adoption

Limited insurance coverage for home-use pulse oximeters is another obstacle holding back market expansion. The Centers for Medicare & Medicaid Services often classifies these devices as "non-essential durable medical equipment," restricting reimbursement unless prescribed for specific conditions. The Kaiser Family Foundation reports that nearly 40% of insured Americans face out-of-pocket costs for uncovered devices, discouraging purchases. Additionally, a study in the American Journal of Managed Care notes inconsistencies in reimbursement policies across states, creating confusion and financial barriers. Without standardized coverage, many households, especially low-income ones, struggle to afford these devices. Advocacy efforts and collaboration with insurers are needed to close these gaps and unlock the full potential of the market.

SEGMENTAL ANALYSIS

By Product Type Insights

In 2024, fingertip oximeters were the biggest segment in the North America pulse oximeter market, holding 65% of the total share . Their popularity came from being small, affordable, and easy to use, making them perfect for home health monitoring. The Centers for Disease Control and Prevention noted that over 16 million Americans had COPD in 2023 , which increased the need for simple tools to track oxygen levels. Fingertip oximeters stood out because they gave quick and accurate readings without requiring special skills. They also fit well with the growing trend of telehealth, as patients could easily share their data with doctors online. These factors made fingertip oximeters a top choice for managing chronic conditions like asthma and heart disease.

On the other hand, handheld oximeters are expected to grow faster than any other segment, with a CAGR of 8.2%. This growth will happen because these devices are versatile and can be used in many places, such as hospitals, ambulances, and rural clinics. According to the American Hospital Association, over 6,000 hospitals in the U.S. depend on portable diagnostic tools during emergencies, which boosts demand for handheld models. These oximeters are durable and can check multiple patients quickly, making them ideal for busy healthcare settings. A study by the National Institutes of Health shows that portable medical devices help doctors diagnose and treat patients faster, improving outcomes. As telemedicine expands, especially in remote areas, handheld oximeters will become even more important for delivering care where it’s hard to access advanced equipment.

By End-use Insights

In 2024, hospitals and other healthcare facilities accounted for the largest share of the North America pulse oximeter market, holding 60% of the total market . This dominance was due to the widespread use of pulse oximeters in critical care units, surgeries, and emergency rooms. According to the American Hospital Association, over 6,100 hospitals in the U.S. relied on advanced diagnostic tools to monitor patients’ oxygen levels during treatment. The high prevalence of chronic diseases also played a role; the Centers for Disease Control and Prevention reported that 60% of adults in the U.S. had at least one chronic condition , driving demand for reliable monitoring devices. Hospitals valued pulse oximeters for their precision and ability to integrate with other medical equipment, making them indispensable in clinical settings.

From 2025 to 2033, home healthcare is expected to grow at the quick rate in the North America pulse oximeter market, with a CAGR of 9.5%. This growth will be driven by the rising trend of managing health conditions at home, especially among aging populations. The U.S. Census Bureau projects that by 2034, older adults will outnumber children , increasing the need for accessible health monitoring tools. Also, the Centers for Medicare & Medicaid Services report that home healthcare spending grew by 8% annually in recent years, reflecting its growing importance. Pulse oximeters are becoming essential for managing conditions like COPD and sleep apnea outside hospitals. Their affordability, ease of use, and integration with telehealth platforms make them ideal for home use, ensuring rapid adoption in the coming years.

REGIONAL ANALYSIS

In 2024, the United States accounted for 85.1% of the North America pulse oximeter market strengthening its position as the largest contributor. This dominance was driven by the country’s advanced healthcare infrastructure and high prevalence of chronic respiratory conditions. According to the Centers for Disease Control and Prevention, over 16 million Americans were diagnosed with chronic obstructive pulmonary disease (COPD) in 2023, creating significant demand for monitoring devices like pulse oximeters. Additionally, widespread adoption of telehealth solutions, which grew by 38 times pre-pandemic levels as per the American Medical Association, further accelerated the use of remote monitoring tools. The U.S. also benefited from favorable reimbursement policies under Medicare and Medicaid, ensuring accessibility for millions of patients.

Between 2025 and 2033, Canada is expected to emerge as the fastest-growing market in the North America pulse oximeter sector, with a projected CAGR of 7.8%. This rapid expansion will be fueled by increasing investments in telemedicine and workplace health initiatives. Statistics Canada shows that telehealth usage surged by 40% during the pandemic , reflecting a cultural shift toward digital healthcare solutions. Furthermore, the Canadian government’s focus on occupational safety, particularly in industries like mining and manufacturing, will drive adoption. A report by the Public Health Agency of Canada reveals that respiratory diseases affect over 3 million Canadians  showing the importance of accessible monitoring tools. Canada’s push for sustainable medical devices will also contribute to this growth trajectory.

KEY MARKET PLAYERS AND COMPETITIVE LANDSCAPE

Stryker, Medtronic, Nihon-Kohden Corporation, GE Healthcare, Koninklijke Philips N.V., Hill-Rom Services, Inc., Smiths Group plc, Honeywell International, Promed Technology Co., Ltd., Contec Medical Systems Co., Ltd., CONMED Corporation, Curbell Medical Products, Inc., Ecomed, Masimo, TytoCare Ltd., and BioIntelliSense, Inc.

The North America pulse oximeter market is highly competitive, with several key players striving to innovate and capture a larger share of the industry. Companies are focusing on making their products stand out by improving technology, affordability, and usability. For instance, some brands are integrating advanced features like artificial intelligence and wireless connectivity to appeal to tech-savvy users and healthcare providers. Others are designing simpler, cost-effective models to attract individual consumers managing health conditions at home.

To strengthen their positions, companies are also forming partnerships with hospitals, clinics, and telehealth platforms. These collaborations help them integrate pulse oximeters into broader healthcare systems, making the devices more accessible. Additionally, many players are investing in educational campaigns to raise awareness about the importance of oxygen monitoring in preventing and managing chronic illnesses.

Despite the dominance of large manufacturers, smaller companies are finding opportunities by targeting niche markets, such as pediatric care or eco-friendly designs. This focus on customization and innovation keeps the competition intense. The growing demand for home healthcare solutions and remote monitoring tools further fuels this rivalry. Overall, the competitive landscape benefits consumers, as it drives advancements in technology, improves affordability, and ensures a wide variety of options tailored to different needs. This dynamic environment continues to shape the future of the pulse oximeter market in North America.

Top Players in the market

Philips Healthcare

Philips Healthcare has established itself as a key player in the North America pulse oximeter market through its commitment to innovation and patient-centric solutions. The company is renowned for integrating advanced technologies, such as artificial intelligence and cloud connectivity, into its pulse oximetry devices. This focus on precision and real-time monitoring has made its products highly reliable for both clinical and home healthcare settings. Philips has also emphasized user-friendly designs, ensuring that its devices cater to a wide range of users, from medical professionals to individuals managing chronic conditions. By aligning with the growing trend of remote patient monitoring and telehealth, Philips has strengthened its position in the market while contributing to improved health outcomes across North America.

Masimo Corporation

Masimo Corporation has carved out a significant niche in the North America pulse oximeter market by prioritizing accuracy and adaptability in its product offerings. The company’s pulse oximeters are celebrated for their ability to provide consistent readings even in challenging conditions, such as low perfusion or motion interference. Masimo’s dedication to addressing unmet clinical needs has enabled it to develop devices that are widely adopted in critical care and surgical environments. Furthermore, the company has been instrumental in promoting the use of pulse oximeters beyond traditional healthcare settings, advocating for their role in preventive health management. By fostering trust among healthcare providers and patients alike, Masimo continues to shape the evolution of pulse oximetry in North America.

Medtronic plc

Medtronic plc has played a pivotal role in advancing the North America pulse oximeter market through its emphasis on durability, reliability, and versatility. The company’s devices are designed to meet the diverse needs of hospitals, clinics, and homecare users, offering solutions that seamlessly integrate into various healthcare ecosystems. Medtronic has consistently focused on enhancing the accessibility of pulse oximeters, ensuring that they remain affordable and easy to use without compromising on quality. Additionally, the company has actively contributed to raising awareness about the importance of oxygen monitoring in managing chronic illnesses. By combining cutting-edge engineering with a patient-first approach, Medtronic has solidified its reputation as a leader in the pulse oximeter market, driving both innovation and adoption across North America.

Top strategies used by the key market participants

Emphasis on Sustainability and Eco-Friendly Design

A growing trend among key players in the pulse oximeter market is the incorporation of sustainable practices into product development. Companies are increasingly prioritizing eco-friendly materials, energy-efficient designs, and recyclable components to align with global environmental goals. By adopting green manufacturing processes and reducing electronic waste, these players are appealing to environmentally conscious consumers and healthcare institutions. This strategy not only enhances brand reputation but also positions pulse oximeters as part of a broader movement toward sustainable healthcare solutions. By addressing environmental concerns, companies are differentiating themselves in a crowded market while contributing to long-term ecological benefits.

Direct-to-Consumer Marketing and Education Campaigns

To strengthen their position, some companies are focusing on direct-to-consumer marketing strategies coupled with educational initiatives. These efforts aim to raise awareness about the importance of oxygen monitoring and the role of pulse oximeters in preventive healthcare. By leveraging digital platforms, social media, and community outreach programs, players are educating consumers about how these devices can help manage conditions like asthma, sleep apnea, and chronic lung diseases. This approach empowers individuals to take charge of their health and encourages self-monitoring at home. By fostering trust and building a deeper connection with end-users, companies are expanding their customer base and driving demand beyond traditional clinical settings.

Customization for Diverse Demographics

Another innovative strategy involves tailoring pulse oximeters to meet the specific needs of diverse demographic groups. Recognizing the limitations of one-size-fits-all solutions, companies are developing specialized devices for children, elderly patients, and individuals with unique health challenges. For instance, pediatric-specific models are designed with smaller sensors and child-friendly interfaces, while devices for seniors emphasize simplicity and ease of use. Additionally, efforts are being made to ensure accuracy across all skin tones and body types, addressing past concerns about inclusivity. By customizing products to cater to underserved populations, companies are not only broadening their market reach but also promoting equitable access to healthcare technology.

Recent Market Developments

• In October 2024, Masimo received FDA approval for its W1 Medical Watch, the only wearable device authorized to continuously track oxygen saturation (SpO2) and pulse rate with medical-grade accuracy. This innovation provides individuals with chronic conditions an advanced solution for continuous health monitoring.
• In December 2024, Nonin Medical obtained FDA 510(k) clearance for its TruO2 OTC fingertip pulse oximeter. This over-the-counter device offers accurate blood oxygen readings across all skin tones, empowering both consumers and healthcare professionals with reliable measurements for informed decision-making.
• In February 2024, Masimo’s Mightysat received FDA clearance as the first over-the-counter medical fingertip pulse oximeter. This device provides consumers with a reliable option to monitor oxygen saturation and pulse rate at home, competing with non-FDA cleared consumer models.
• In February 2025, Google’s Pixel Watch 3 received FDA clearance for its Loss of Pulse Detection feature. This feature, which automatically contacts emergency services if it detects a loss of pulse, is expected to enhance user safety and emergency response.
• In January 2025, the FDA proposed new guidance to improve the accuracy of blood oxygen monitoring devices across different skin tones. This initiative aims to ensure reliable device performance for all users by recommending manufacturers collect diverse clinical data.

MARKET SEGMENTATION

This research report on the North American pulse oximeter market has been segmented and sub-segmented into the following categories.

By Type

• Handheld Oximeters
• Fingertip Oximeters
• Tabletop Oximeters

By End-use

• Hospitals & Other Healthcare Facilities

• Homecare

By Country

• The United States

• Canada

• Rest of North America