U.S. Medical Devices Market Size to Surpass USD 367.77 Billion by 2034

According to latest report, the U.S. medical devices market size is calculated at 33.29 billion in 2025 and is projected to surpass USD 367.77 billion by 2034 with a remarkable CAGR of 6.9% from 2025 to 2034.

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The U.S. medical devices market is expanding owing to the significant growth in the demographic shift over the years. According to the data published by the University of Washington on demographic research projection, every second individual born in the 21st century is anticipated to live more than 100 years. Thus, the increasing geriatric population and age-related chronic disorders like eye diseases, heart diseases, cataracts, osteoporosis, hypertension, and Alzheimer's are major driving factors for the market. These factors increased awareness among the people undergoing various treatments at the initial stage of the disease. The growing demand for treatments encourages market payers to launch advanced devices into the healthcare sector.

For instance, in April 2024, Boston Scientific Corporation started the navigate-PF study of the FARAVIEW software module. The study aims to visualize and track the FARAWAVE Nav Pulsed Field Ablation catheter for patients suffering from paroxysmal and persistent Atrial Fibrillation. Such advanced devices are responsible for market expansion.

AI integration in the medical devices sector is revolutionizing healthcare delivery by addressing supply and demand challenges due to the increasing population's healthcare issues. The increasing use of multimodal data integrated with Artificial intelligence transforms healthcare delivery through AI-powered healthcare systems. For instance, in March 2023, Medtronic joined hands with NVIDIA Corp to build an AI platform for medical devices. It has integrated NVIDIA healthcare and edge AI technologies into Medtronic's GI genius intelligent endoscopy module.

U.S. Medical Device Market Report Scope

Medical Device Classes: What Are Class I, II, and III Medical Devices?

Classifications are generally assigned to medical devices based on both potential risk to the patient and the level of FDA regulatory control required to market the device. As the classification level increases, so does patient risk and regulatory control.

Class I Devices

Medical devices in the Class I category have the least amount of regulatory control and minimal potential harm to the patient. These devices are relatively simple to design, manufacture, and use. Examples of Class I medical devices are hospital beds, oxygen masks, tongue depressors, and arm slings.

Class II Devices

Class II medical devices require more FDA regulation to assure safety and effectiveness. X-ray systems, contact lenses, syringes, and blood transfusion kits all fall under this medical device classification.

Class III Devices

Products used to support or sustain human life or those that present a potentially high risk for a patient are in the Class III classification. These devices are, understandably, more rigorously regulated than Class II or Class I products and require additional levels of approval. Heart valves, cochlear implants, and defibrillators are examples of Class III medical devices.

Market Trends:

•  Rising shift to use wearable medical devices in the U.S.- the rising emphasis on fitness among adults in the U.S. and their focus on the diagnosis and real-time monitoring of people is a major driving factor for the market. Patients and people have awareness about health, preferably using wearable medical devices, making it easier to pre-detect any health issue. According to the data revealed in 2023 by the American Heart Association, nearly 29% of U.S. adults used wearable devices.

•  Increased collaboration among leading players- the major factor augmenting the U.S. medical devices market is increasing demand among the population to use wearable medical devices, enabling leading market players to launch innovative and technically sound healthcare device

•  Strong emphasis on R&D- medical device manufacturers with a strong hold on research and development, owing to the increasing demand for such innovative devices, have been inclined to present smart medical devices in the market over recent years. The increasing focus on R&D and breakthrough technologies further accelerates the U.S. medical device market.

•  Increased collaborations and acquisitions- the leading healthcare market players are looking to adopt techniques that foster their presence. Thus, many players are collaborating as joint ventures and start-ups to develop devices with cutting-edge technology. For instance, in April 2024, Johnson and Johnson Services Inc. agreed to acquire Shockwave Medical to strengthen its CVD’s medical devices product range.

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Segment insights

By Type

The cardiovascular devices segment dominated the medical devices market in 2024. Since heart diseases remains one of the leading causes of death worldwide, they require regular monitoring to manage conditions. Cardiac monitoring devices have proven to be effective in monitoring cardiac health. The prevalence of cardiovascular disease (CVDs) has increased significantly due to factors such as lifestyle changes, stress, and unhealthy eating habits, boosting the demand for cardiovascular devices for diagnostics as well as surgical purposes. In addition, the advent of modern devices, such as wearable ECG monitors, smartwatches, and advanced Holter monitors equipped with sensors to detect abnormalities in heart rhythm and other vital signs, contribute to segmental dominance.

The diagnostic imaging segment is expected to expand at a significant growth rate in the coming years. The increasing awareness about early disease detection is a major factor boosting the demand for diagnostic devices. The rising prevalence of chronic diseases further supports segmental growth, as these diseases require timely diagnosis. Rising advancements in imaging technologies further improve the accuracy of diagnostic imaging, enhancing patient outcomes.

The diabetes care segment is projected to grow at a notable rate during the forecast period. The segmental growth is attributed to the rising prevalence of diabetes worldwide. According to the WHO, approximately 830 million people worldwide have diabetes. More than half of people living with diabetes are not receiving treatment. Diabetes care devices, such as continuous glucose monitoring, emerged as a promising approach to managing diabetes. In addition, the rising awareness about the adverse impact of untreated diabetes contributes to segmental growth.

By End-user

The hospitals & ambulatory surgery centers (ASCs) segment dominated the medical devices market in 2024. This is mainly due to increased patient pool and admission rates in these settings. Hospitals and ASCs are considered primary care centers. Moreover, these settings are often equipped with advanced medical devices, such as monitoring, diagnostics, and surgical devices, appealing to a broader patient base to perform procedures. The increasing shift toward outpatient settings, such as ASCs, further contributes to market expansion.

The clinics segment is likely to grow at a considerable rate over the studied period. The rising demand for personalized care is a major factor driving the growth of the segment. Clinics focus on patient-centric care approaches that enhance patient care. Furthermore, the availability of skilled healthcare professionals encourages people to receive care from these settings.

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U.S. Medical Devices Market Top Key Companies:

•   Medtronic

•   Johnson & Johnson

•   Abbott Laboratories

•   Stryker Corporation

•   Becton, Dickinson and Company (BD)

•   Boston Scientific

•   Zimmer Biomet

•   Edwards Lifesciences

•  Intuitive Surgical

•  Hologic

Recent Developments:

•  In June 2024, Stryker introduced a clinically advanced monitor/defibrillator, LIFEPAK 35. This device offers advanced technology and is built on a highly sensitive platform designed to improve patient care.

•  In April 2024, Abbott received U.S. FDA approval for its edge-to-edge repair system, the TriClip G4 transcatheter, primarily used to treat tricuspid regurgitation.

• In May 2023, Stryker launched its ortho Q guidance system, which aids advanced surgical planning and proper guidance for hip and knee treatments and procedures that professionals from the sterile field can smoothly control to avoid infections.

U.S. Medical Devices Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2034. For this study, Statifacts has segmented the global U.S. Medical Devices Market

By Type

•  Diagnostic Imaging

•  Orthopedic Devices

•  Cardiovascular Devices

•  Minimally Invasive Surgical (MIS)

•  Wound Management

•  Diabetes Care

•  Ophthalmic Devices

•  General Surgery

•  Dental Devicess

•  In Vitro Diagnostics (IVD)

•  Others

By End-user

•  Hospitals & Ambulatory Surgery Centers (ASCs)

•  Clinics

•  Others

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