According to latest report, the U.S. wearable medical device market size is calculated at 14.79 billion in 2025 and is projected to surpass USD 120.09 billion by 2034 with a remarkable CAGR of 26.2% from 2025 to 2034. Government initiatives, technological advancements, and demand in the healthcare sector have driven the market demand.
Buy this Databook (Price USD1550) https://www.statifacts.com/order-report/7966
U.S. Wearable Medical Devices Market Report Highlights
• Based on product, the diagnostic devices segment dominated the market and accounted for a share of 64.3% in 2024 due to growing demand for personalized medicine, remote patient monitoring, and Cost-effectiveness
• Based on site, the strap, clip, and bracelet segment is expected to grow at the fastest CAGR over the forecast period. The shoe sensors segment is anticipated to witness lucrative growth over the forecast period
• Based on application, the home healthcare segment dominated with the largest market revenue share of 55.2% in 2024. This is attributable to the rising prevalence of chronic diseases involving diabetes, asthma, and cardiac diseases and the rising geriatric population in the U.S.
• The FDA classifies wearable medical devices based on their intended use and level of risk. Low-risk devices involving fitness trackers are classified as Class I medical devices and do not require pre-market approval (PMA).
The Wearable medical equipment, such as fitness trackers and smartwatches, exemplifies the innovative use of technology in healthcare. These devices are designed to monitor and gather comprehensive data regarding a user’s health and fitness metrics. The market for wearable medical devices is experiencing robust growth, fueled by escalating investments, funding, and grants, as well as a rising preference for wireless connectivity among healthcare providers, which enhances real-time monitoring capabilities. As technological advancements continue to improve functionality, the appeal of these wearable devices is expected to increase, particularly in remote healthcare environments and for at-home patient management. The surge in demand for remote patient monitoring solutions, coupled with a growing interest in home healthcare options, is anticipated to boost the U.S. wearable medical devices market.
Additionally, an increasing number of consumers are prioritizing fitness and adopting healthier lifestyles, serving as a key driver behind the heightened interest and demand for these products. In recent years, the healthcare industry has witnessed a dramatic rise in the volume and complexity of data due to the introduction of sophisticated data collection and analytical tools. Ongoing research is actively exploring the integration of Artificial Intelligence (AI) and machine learning technologies into wearable medical devices, a development that is likely to further amplify the volume of data generated within this sector. This convergence of cutting-edge technologies is pivotal for healthcare providers, enabling them to detect early changes in cardiac functions and initiate timely interventions that could prevent re-hospitalization and lower the rates of heart failure.
Elevate your business strategy with Statifacts. Improve efficiency and achieve better outcomes—schedule a consultation today! https://www.statifacts.com/schedule-meeting
U.S. Wearable Medical Devices Market Report Scope
|
Report Attribute |
Details |
|
Revenue forecast in 2034 |
USD 120.09 billion |
|
Growth Rate |
CAGR of 26.2% from 2024 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2018 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD billion and CAGR from 2024 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Product, site, application, grade type, distribution channel |
|
Country scope |
U.S. |
|
Key companies profiled |
Koninklijke Philips N.V.; Apple Inc.; Fitbit; Basis Science; Garmin; Medtronic; Omron Corp.; Withings; Vital Connect; Polar Electro; Everist Genomics; Intelesens Ltd.; Sotera Wireless; AbbVie Inc. |
Immediate Delivery Available | Buy This Premium Databook ( Price USD 1550 ) https://www.statifacts.com/order-report/7966
AI Integration in Wearable Devices Is a Natural Fit
The incorporation of AI is transforming wearable sensors, enhancing their accuracy and operational efficiency by identifying and rectifying discrepancies in collected data. For example, any inaccuracies found in heart rate measurements can be corrected, thereby ensuring the devices maintain a high level of reliability and precision. Moreover, advanced AI algorithms can sift through the substantial datasets amassed by these wearable devices, allowing healthcare professionals to discern patterns, anticipate health outcomes, and make informed decisions regarding patient care. By analyzing various parameters such as an individual's activity level, sleep quality, and heart rate fluctuations, AI can predict the potential risk of severe health events like heart attacks or strokes, thus empowering healthcare providers to implement preventative measures. Additionally, in scenarios involving multimodal sensing and cross-sensitivity challenges—where one signal's measurement may be affected by the presence of other signals—AI-driven pattern recognition models can be employed.
U.S. Wearable Medical Devices Market Trends
• The Rise of Digital Therapeutics: There is a significant momentum building in the development of devices designed for remote patient monitoring and at-home diagnostics, reflecting a transformative shift in how healthcare is delivered. This emerging landscape allows healthcare providers to adopt a more proactive approach to patient care, effectively alleviating the pressures faced by traditional healthcare facilities. Digital therapeutics, which leverage sophisticated software solutions for the management and treatment of various medical conditions, are increasingly being integrated with wearable devices. These combinations enable more effective interventions and support for patients outside the clinical environment.
• Advancements in Biometric Devices: Wearable devices designed to track vital signs, such as heart rate, blood pressure, and glucose levels, are evolving to be more advanced and precise. These sophisticated biometric sensors provide healthcare professionals with enriched datasets that offer personalized insights into patients' health. As a result, diabetes management systems, heart disease monitoring, and other chronic disease management strategies are benefitting from real-time data, allowing for more tailored and effective treatment plans.
• Sustainability in Medical Device Manufacturing: In response to growing concerns about environmental sustainability, medical device manufacturers are increasingly prioritizing Environmental, Social, and Governance (ESG) factors in their operations. This shift is promoting the adoption of sustainable manufacturing practices and eco-friendly design principles. Companies are innovating in materials sourcing and lifecycle management.
• Cybersecurity Challenges: As the proliferation of connected medical devices escalates, so too do concerns surrounding cybersecurity. Protecting sensitive patient data is becoming critical, prompting the development of more robust security measures. Manufacturers and healthcare providers are investing in cutting-edge encryption techniques and cybersecurity protocols to safeguard against potential data breaches and ensure patient trust in these technologies.
• Integration of Artificial Intelligence: Artificial Intelligence (AI) is playing a pivotal role in processing the vast volumes of data generated by wearable devices. Sophisticated AI algorithms are being employed to analyze this data, identifying patterns and predicting health risks with remarkable accuracy. This technological integration enables healthcare providers to offer personalized recommendations.
U.S. Wearable Medical Devices Market Segment Insights
Site Insights
By site, the strap/clip/bracelet segment held a dominant presence in the market in 2024. This segment is expected to maintain its dominance throughout the forecast period. Smartwatches, which offer functionalities such as mobility tracking, respiratory rate monitoring, and pulse rate assessment, paired with Bluetooth and cloud connectivity, are anticipated to propel significant growth in this area. The multifunctional capabilities of these devices make them increasingly appealing to consumers seeking comprehensive health monitoring solutions.
Product Insights
By product, the diagnostic devices segment registered its dominance over the U.S. wearable medical devices market in 2024, primarily driven by the rising prevalence of neurological disorders. This segment's growth is significantly fueled by heightened awareness among consumers regarding the effectiveness of neurological wearables, which are designed to monitor cognitive functions during daily activities continuously. These devices enable individuals to track their cognitive health in real time, thereby enhancing the early detection and management of issues.
In contrast, the therapeutic devices segment is poised to experience the most rapid growth throughout the forecast period. This surge is largely attributed to the increasing introduction of innovative therapeutic devices into the market. Among these are intelligent tools for asthma management, advanced wearable pain relief devices, and cutting-edge insulin management systems. The robust pipeline of these therapeutic solutions strengthens the segment’s potential for expansion, addressing pressing healthcare needs.
Application Insights
In terms of application, the home healthcare segment has emerged as the dominant force in the U.S. wearable medical devices market. This dominance is closely linked to the growing geriatric population, which is often accompanied by a rise in chronic disease prevalence. Additionally, home healthcare emerges as a cost-effective strategy to manage rising healthcare expenses, making it a notable field in the sector.
The remote patient monitoring application is predicted to grow at the fastest rate during the forecast period. This growth can be attributed to the increasing American geriatric population, coupled with the high prevalence of chronic conditions that necessitate continuous monitoring and management, ensuring better health outcomes for patients.
Grade Type Insights
When examining the U.S. wearable medical devices market by device grade type, the consumer-grade wearable healthcare devices segment leads with the highest revenue share. These devices are characterized by their user-friendly features, focusing on personal health and fitness tracking, which have made them exceptionally popular among health-conscious consumers. Factors such as convenience, affordability, and a growing awareness of health issues significantly enhance the performance of this segment, marking it as a key driver in the space.
On the other hand, the clinical-grade wearable healthcare devices segment is expected to grow the fastest over the forecast period. This growth is driven by an increasing demand for sophisticated monitoring solutions in clinical environments. The rising adoption of clinical-grade devices for ongoing patient monitoring, effective remote healthcare management, and seamless integration with existing healthcare systems plays a crucial role in this segment's rapid advancement.
Distribution Insights
With regard to distribution channels, the pharmacies segment currently commands the largest revenue share. This is largely because pharmacies are widely accessible and serve as convenient points for consumers to purchase wearable medical devices. Additionally, pharmacies function as health and wellness hubs, providing customers with expert advice, which solidifies their role as significant contributors to the U.S. wearable medical devices market.
Conversely, the online channel is projected to grow at the fastest rate in the coming years. This trend is fueled by consumers' increasing preference for online shopping, attracted by the convenience, accessibility, and vast selection of products offered through e-commerce platforms.
U.S. Wearable Medical Device Market Top Key Companies:
• Koninklijke Philips N.V.
• Apple Inc.
• Fitbit
• Basis Science
• Garmin
• Medtronic
• Omron Corp.
• Withings
• Vital Connect
• Polar Electro
• Everist Genomics
• Intelesens Ltd.
• Sotera Wireless
• AbbVie Inc.
Recent Developments
• In 2024, Apple Inc. launched a vision health tracker in the health app for iWatch and iPhone. This is expected to increase the adoption and application of the feature to improve eye health from myopia conditions and increase the customer base
• In January 2024, Garmin unveiled the Lily 2 series smartwatches, introducing enhanced health, wellness, and connectivity features. This announcement is expected to impact the wearable medical devices market by introducing refined and fashionable smartwatches with advanced health and wellness features
• In January 2024, Sennheiser collaborated with Polar Electro to launch the Momentum Sport earbuds, marking the first time Polar's bio-sensing capabilities extend beyond its products. This collaboration is poised to impact the wearable medical devices market by expanding bio-sensing capabilities into audio devices for enhanced fitness monitoring and guidance
• In January 2024, Fitbit and Quest Diagnostics announced a collaboration project to study the capacity of wearable devices to enhance metabolic health. The study aims to evaluate the effect of wearables on users' behaviors.
U.S. Wearable Medical Devices Market Report Segmentation
This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Statifacts has segmented the U.S. wearable medical devices market report based on product, site, application, grade type, and distribution channel.
By Product
• Diagnostic Devices
o Vital Sign Monitor
o Heart Rate Monitors
o Activity Monitors
o Electrocardiographs
o Pulse Oximeters
o Spirometers
o Blood Pressure Monitors
o Others
• Sleep Monitoring Device
o Sleep Trackers
o Wrist Actigraphs
o Polysomnographs
o Others
• Electrocardiographs Fetal & Obstetric Devices
• Neuromonitoring Devices
o EEG
o EMG
o Others
• Therapeutic Devices
• Pain Management Devices
o Neurostimulation Devices
o Others
• Insulin Monitoring Devices
o Insulin Pumps
o Others
o Autoinjectors
o Other Insulin Devices
• Rehabiliation Devices
o Accelerometers
o Sensing Devices
o Ultrasound Platform
o Others
• Respiratory Therapy Devices
o Ventilators
o CPAP
o Portable Oxygen Concentrators
o Others
By Site
• Handheld
• Headband
• Strap, Clip, Bracelet
• Shoe Sensors
• Others
By Application
• Sports & Fitness
• Remote Patient Monitoring
• Home Healthcare
By Grade Type
• Consumer-grade Wearable Medical Devices
• Clinical Wearable Medical Devices
By Distribution Channel
• Pharmacies
• Online Channels
• Hypermarkets
Immediate Delivery Available | Buy This Premium Databook ( Price USD 1550 ) https://www.statifacts.com/order-report/7966
Browse More Research Reports ;
USA: +1 804 441 9344
APAC: +61 485 981 310 or +91 87933 22019
Europe: +44 7383 092 044
Email: sales@statifacts.com
Web: https://www.statifacts.com/
Web : https://www.novaoneadvisor.com/
You can place an order or ask any questions, please feel free to contact at sales@statifacts.com | +1 804 441 9344
