Smart Medical Devices Market Report and Forecast 2025-2034

The global smart medical devices market was valued at USD 39.10 Billion in 2024, driven by the rising awareness regarding the benefits of physical health across the globe. The market is anticipated to grow at a CAGR of 7.50% during the forecast period of 2025-2034 to achieve a value of USD 80.59 Billion by 2034.

Smart Medical Devices Market Overview

Smart medical devices are advanced technologies designed to improve patient care through real-time monitoring, diagnostics, and data analysis. These devices, such as wearables, smart sensors, and diagnostic tools, are equipped with sensors, connectivity, and AI capabilities to track health metrics like heart rate, blood pressure, and glucose levels. By transmitting data to healthcare providers, they enable continuous monitoring, early detection of health issues, and personalised treatment. With applications across chronic disease management, remote patient care, and wellness, smart medical devices are transforming healthcare by enhancing precision, efficiency, and patient outcomes.

Smart Medical Devices Market Growth Drivers

Surge in FDA Approvals to Boost Market Growth

The increasing adoption of personalised healthcare, along with the rising demand for automation in medical procedures, is driving growth in the market. For instance, in January 2025, Saluda Medical received FDA approval for its biomarker-based, automated programming platform for spinal cord stimulation (SCS), known as EVA. This innovative platform enhances patient programming by autonomously analysing and adjusting therapy settings based on individual biomarkers, such as evoked compound action potentials (ECAPs). The EVA system reduces manual programming, optimises care, and improves the patient experience, streamlining workflow in busy clinics. This advancement is poised to drive growth in the market by enhancing the efficiency and effectiveness of treatments, meeting the increasing demand for smart, patient-centric devices.

AI Integration to Boost Smart Medical Devices Market Demand

With the rising demand for artificial intelligence (AI) and automation in medical diagnostics, the market is witnessing strong growth. For instance, in December 2024, Royal Philips introduced the CT 5300 system, which integrates AI and smart workflow automation to streamline the CT scanning process. The system’s AI-powered ‘Precise’ software assists at every stage, automating time-consuming tasks and freeing radiologists and technicians to focus on patient care. This technology optimises efficiency, improves diagnostic accuracy, and reduces clinician workload. The widespread adoption of such AI-integrated systems is expected to propel market growth in the forecast period, particularly within diagnostic imaging.

Smart Medical Devices Market Trends

The market is witnessing several trends and developments to improve the current scenario. Some of the notable trends are as follows:

Adoption of Wearable Smart Devices to Enhance Market Value

Wearable smart devices, such as fitness trackers, heart rate monitors, and smartwatches, are rapidly gaining traction due to their ability to monitor health metrics in real-time and provide continuous patient data. These devices enable remote monitoring of chronic conditions, allowing healthcare providers to intervene early and manage patients' conditions more effectively. For instance, in March 2024, the U.S. Food and Drug Administration approved the first over-the-counter (OTC) continuous glucose monitor (CGM), the Dexcom Stelo Glucose Biosensor System. The system consists of a wearable sensor connected to an application on a user’s smartphone or smart device. It continuously monitors, records, analyses, and displays glucose levels for individuals aged 18 and above who are not on insulin and do not experience severe hypoglycemia. The increasing adoption of wearables is driven by the growing awareness of personal health and wellness, as well as the need for remote patient care, especially post-pandemic. This trend is expected to drive market growth as demand for wearable smart medical devices continues to rise globally.

Increase in Chronic Disease Management to Fueling Smart Medical Device Market Value

The rising prevalence of chronic diseases, such as diabetes, hypertension, and cardiovascular diseases, is driving the adoption of smart medical devices for continuous monitoring and management. Smart devices, including insulin pumps, blood glucose monitors, and remote ECGs, allow for real-time data collection, enabling better disease management and improving patient outcomes. As of 2021, the IDF Diabetes Atlas reports that 10.5% of adults (20-79 years) have diabetes, with nearly half undiagnosed. By 2030, cases are projected to reach 643 million, rising to 783 million by 2045, a 46% increase. Currently, 537 million adults live with diabetes, with 75% in low- and middle-income countries. Over 90% have type 2 diabetes, driven by urbanisation, an ageing population, reduced physical activity, and rising obesity rates. These trends highlight the growing global diabetes burden, impacting individuals, healthcare systems, and economies worldwide. As healthcare systems increasingly focus on preventative care and long-term disease management, the demand for smart medical devices will continue to grow. This trend is expected to significantly contribute to market expansion, making smart medical devices an integral part of modern healthcare infrastructure.

Rising Artificial Intelligence (AI) Integration to Augment Smart Medical Device Market Size

The integration of Artificial Intelligence (AI) into smart medical devices is revolutionising healthcare by enhancing diagnostic capabilities, optimising patient care, and enabling personalised treatments. AI-driven devices, such as smart wearables and diagnostic tools, can process large amounts of data in real time, enabling healthcare providers to make faster, more informed decisions. For instance, in October 2024, Olympus Europa SE & Co. KG announced that its group company, Odin Medical Ltd, received CE-MDR approval for its cloud-AI endoscopy devices, CADDIE, CADU, and SMARTIBD, enhancing clinical outcomes and efficiency. The demand for AI-powered smart devices is expected to grow as the technology becomes more affordable and accessible. This trend is driving the global smart medical devices market, significantly improving patient outcomes and reducing healthcare costs, ensuring its expansion throughout the forecast period.

Evolving Regulatory Landscape to Boost Smart Medical Devices Market Demand

The growing demand for multi-functional, smart wearable devices is shaping a key trend in the market. For instance, in February 2025, EssilorLuxottica received FDA approval for its over-the-counter Nuance Audio Glasses, a revolutionary product combining open-ear hearing aid functionality with smart glasses. The device also received CE marking under the EU’s Medical Devices Regulation, alongside an ISO certification for Hearing Aids, enabling a simultaneous launch in the US and Europe. This approval paves the way for the introduction of advanced hearing solutions that seamlessly integrate with daily life, driving growth in the smart hearing device segment. The success of these audio glasses could set the stage for further innovation and expansion in the wearable medical devices market.

Smart Medical Devices Market Segmentation

Smart Medical Devices Market Report and Forecast 2025-2034 offers a detailed analysis of the market based on the following segments:

Market Breakup by Device Type

• Diagnostic and Imaging Devices
• Blood Glucose Monitors
• EEG/ECG Monitors
• Blood Pressure Monitors
• Others
• Therapeutic Devices
• Portable Oxygen Concentrators
• Neuro-simulators
• Hearing Aids
• Others
• Injury Prevention and Rehabilitation Devices
• Body Motion Devices
• Fall Detection Devices
• Others

Market Breakup by Type

• Portable
• Wearable
• Others

Market Breakup by End User

• Hospitals and Clinics
• Homecare Settings
• Ambulatory Surgical Centers
• Others

Market Breakup by Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa

Smart Medical Devices Market Share

Blood Glucose Monitors to Lead the Segment by Device Type

Blood glucose monitors are poised to hold the largest market share due to the rising prevalence of diabetes and the increasing adoption of self-monitoring solutions. The growing diabetic population, advancements in continuous glucose monitoring (CGM) technology, and the shift towards non-invasive monitoring methods are key market drivers. As per the analysis by Expert Market Research, the global glucose monitoring devices market is anticipated to grow at a CAGR of 11.3% during the forecast period of 2025-2034. Furthermore, integration with smartphones and wearable technologies enhances user convenience and data tracking. With governments and healthcare organisations promoting diabetes management, this segment is set to drive market growth, ensuring widespread adoption and improved patient outcomes in the forecast period.

Wearable Devices to Dominate the Smart Medical Devices Market by Type

Wearable smart medical devices are expected to dominate the market, driven by increasing consumer awareness, advancements in sensor technology, and growing demand for real-time health monitoring. These devices, including smartwatches, ECG monitors, and biosensors, enable continuous tracking of vital health parameters, improving preventive care and chronic disease management. The integration of artificial intelligence (AI) and cloud-based analytics further enhances their functionality. As per the analysis by Expert Market Research, the global IoMT wearable devices market is expected to grow at a CAGR of 23.0% during the forecast period of 2025-2034. As consumers prioritise personalised healthcare and remote patient monitoring gains traction, the wearable segment is set to experience exponential growth, playing a crucial role in shaping the future of smart medical devices globally.

Homecare Settings to Lead the Smart Medical Devices Market Segmentation by End User

Homecare settings are projected to hold the largest market share, driven by the growing demand for remote patient monitoring and the shift towards decentralised healthcare. Ageing populations, rising chronic disease prevalence, and increasing healthcare costs are encouraging patients to manage their conditions at home using smart devices. Technological advancements, including AI-powered monitoring systems and user-friendly interfaces, make home-based care more efficient. With governments and insurers supporting telehealth initiatives, homecare settings are expected to drive market expansion, improving accessibility and reducing hospital dependency in the forecast period.

Smart Medical Devices Market Analysis by Region

North America is expected to dominate the smart medical devices market due to strong healthcare infrastructure, high adoption of advanced technologies, and increasing demand for remote patient monitoring. The region benefits from extensive R&D investments, supportive regulatory policies, and rising chronic disease cases driving smart device adoption. Europe follows closely, supported by government initiatives and digital healthcare expansion. Asia Pacific is witnessing rapid growth, driven by improving healthcare access and tech-driven solutions. Latin America and the Middle East & Africa are expanding steadily, with increasing awareness and investments in smart healthcare solutions fuelling market penetration in these regions.

Leading Players in the Smart Medical Devices Market

The key features of the market report comprise patent analysis, grants analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:

BPL Medical Technologies

Headquartered in Bengaluru, India, BPL Medical Technologies was established in 1963 and is a leading player in the smart medical devices market. The company specialises in innovative healthcare solutions, offering advanced patient monitoring systems, ventilators, electrocardiographs (ECGs), and defibrillators. BPL Medical Technologies focuses on digital healthcare, integrating AI-powered diagnostics and IoT-enabled devices for enhanced patient care. With a strong presence in emerging markets, the company continues to expand its smart medical devices portfolio, supporting improved diagnostics and treatment across hospitals, clinics, and homecare settings. In October 2024, the company inaugurated its second manufacturing plant in Bengaluru. This showcases a significant step in the expansion of the capabilities of the company to provide world-class medical technology solutions.

CAIRE Inc

Founded in 1965 and headquartered in Georgia, USA, CAIRE Inc. is a global leader in respiratory care solutions. The company specialises in smart medical devices, particularly oxygen therapy systems, including portable and stationary oxygen concentrators with advanced connectivity features. CAIRE’s product range integrates remote monitoring, mobile app compatibility, and AI-driven insights to enhance patient care. The company serves hospitals, homecare providers, and military healthcare sectors, ensuring reliable and efficient oxygen therapy. With continuous innovation, CAIRE Inc. strengthens its position in the smart medical devices market, improving respiratory health worldwide.

Cavagna Group S.P.A

Cavagna Group S.P.A, established in 1949 and headquartered in Brescia, Italy, is a prominent provider of gas control solutions, including smart medical devices. The company develops technologically advanced medical gas regulators, valves, and cylinder systems used in hospitals and homecare settings. Cavagna integrates digital monitoring capabilities into its devices, enabling real-time tracking of gas flow and pressure for enhanced safety and efficiency. With a strong global presence, the company continues to innovate in medical gas technology, supporting healthcare providers with reliable, high-performance solutions for oxygen therapy and other medical applications.

Drive DeVilbiss International

Drive DeVilbiss International, headquartered in Pennsylvania, USA, was founded in 2000 and is a leading provider of smart medical devices for mobility and respiratory care. The company offers a diverse portfolio, including CPAP machines, oxygen concentrators, nebulisers, and advanced mobility aids with integrated smart technology. Drive DeVilbiss focuses on user-friendly, digitally connected solutions that enhance patient independence and homecare management. With operations spanning multiple countries, the company remains at the forefront of smart medical innovations, ensuring improved accessibility and quality of life for individuals requiring assistive healthcare devices.

Other key players in the market include GCE Group, Inogen Inc., Koninklijke Philips N.V., Longfian Scitech Co. Ltd, Nidek Medical Products Inc., Murata Vios, BioTelemetry (Phillips Company), Smart Medical, Dr Trust, and Medtronic.

Key Questions Answered in the Global Smart Medical Devices Market

• What was the global smart medical devices market value in 2024?
• What is the smart medical devices market forecast outlook for 2025-2034?
• What is market segmentation based on device type?
• What is market segmentation based on type?
• What is market segmentation based on end users?
• What are the major factors aiding the smart medical devices market demand?
• How has the market performed so far and how is it anticipated to perform in the coming years?
• What are the market's major drivers, opportunities, and restraints?
• What are the major smart medical devices market trends?
• Which device type will lead the market segment?
• Which type will lead the market segment?
• Which end user will lead the market segment?
• Who are the key players involved in the smart medical devices market?
• What is the patent landscape of the market?
• What are the current unmet needs and challenges in the market?
• How are partnerships, collaborations, mergers, and acquisitions among the key market players shaping the market dynamics?

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