North America mHealth Device Industry Market Report: Strategic Insights

Key Insights

The North American mHealth device market, valued at $39.96 billion in 2025, is experiencing robust growth, projected to expand at a Compound Annual Growth Rate (CAGR) of 24.68% from 2025 to 2033. This surge is driven by several key factors. The increasing prevalence of chronic diseases like diabetes and heart conditions necessitates continuous monitoring and management, fueling demand for remote patient monitoring (RPM) devices. Technological advancements, including the development of smaller, more user-friendly devices with improved connectivity, are further enhancing market appeal. Moreover, the rising adoption of telehealth services, spurred by the COVID-19 pandemic, has created a favorable environment for mHealth solutions. Government initiatives promoting digital health and value-based care are also contributing significantly to market expansion. Strong support from major stakeholders like mobile operators, healthcare providers, and technology companies ensures continuous innovation and wider accessibility of mHealth devices. The market segmentation reveals strong growth across various device types, notably blood glucose monitors, cardiac monitors, and RPM devices, reflecting the diverse healthcare needs of the population.

Significant regional variations within North America exist, with the United States likely holding the largest market share due to its advanced healthcare infrastructure, higher adoption rates of technology, and robust reimbursement policies. Canada and Mexico are also experiencing growth, though at potentially slower rates compared to the US, influenced by varying healthcare systems and levels of technological penetration. However, increasing investment in healthcare infrastructure and the growing awareness of the benefits of remote healthcare are expected to drive market growth in these regions. Competition within the market is fierce, with established players like Medtronic, Philips, and Boston Scientific alongside tech giants like Apple and Samsung vying for market dominance. Future growth will be influenced by factors such as regulatory approvals, data security concerns, and the ongoing development of integrated, comprehensive mHealth platforms.

North America mHealth Device Industry Market Composition & Trends

This comprehensive report provides a detailed analysis of the North America mHealth device industry, covering the period 2019-2033. The market is experiencing significant growth driven by technological advancements, increasing adoption of remote patient monitoring, and a rising prevalence of chronic diseases. We examine market concentration, revealing a competitive landscape with key players such as MobileSmith, Oracle (Cerner Corporation), Care Innovations LLC, eClinicalWorks, Koninklijke Philips N V, Cisco Systems Inc, Veradigm (Allscripts Healthcare LLC), Medtronic PLC, Boston Scientific Corporation, Telus Health, AT&T Inc, Apple Inc, and Samsung Healthcare Solutions. Market share distribution amongst these players will be analyzed, showcasing the competitive dynamics and strategies employed. The report also details the impact of mergers and acquisitions (M&A), with estimated deal values exceeding $xx Million in the historical period (2019-2024). Innovation is a key driver, fueled by advancements in sensor technology, data analytics, and mobile connectivity. We discuss the regulatory landscape, including FDA approvals and compliance standards, and analyze the influence of substitute products and services on market growth. Finally, the report profiles key end-users, including healthcare providers, mobile operators, and application/content players, and evaluates their evolving needs and preferences.

• Market Size (2025): $xx Million
• CAGR (2025-2033): xx%
• M&A Deal Value (2019-2024): >$xx Million
• Market Share Distribution (2025): Detailed breakdown by leading players.

North America mHealth Device Industry Industry Evolution

The North American mHealth device industry has witnessed a transformative evolution during the study period (2019-2033). Driven by technological breakthroughs in areas like AI-powered diagnostics, wearable sensors, and cloud-based data management, the market has exhibited significant growth. From 2019 to 2024, the market expanded at a CAGR of xx%, reaching an estimated value of $xx Million in 2025. This trajectory reflects the increasing adoption of remote patient monitoring (RPM) solutions, particularly within chronic disease management, post-acute care, and wellness programs. The shift towards value-based care models further fuels market expansion as healthcare providers seek cost-effective solutions to improve patient outcomes. Technological advancements, including the miniaturization of sensors, enhanced data security protocols, and the development of user-friendly interfaces, are pivotal to market growth. Consumer preferences are also shifting towards personalized and proactive health management tools, creating a demand for sophisticated mHealth devices and integrated platforms. We project a continued expansion throughout the forecast period (2025-2033), with growth rates potentially influenced by factors such as advancements in 5G network capabilities and increasing insurance coverage for telehealth services.

Leading Regions, Countries, or Segments in North America mHealth Device Industry

The North American mHealth device market exhibits strong regional variations. While the exact rankings require further analysis, preliminary data suggests that certain segments and regions lead the way.

By Service Type:

• Chronic Disease Management: This segment is anticipated to dominate, driven by the high prevalence of conditions like diabetes, cardiovascular diseases, and respiratory illnesses.
• Remote Patient Monitoring (RPM): Rapid growth is seen in RPM services across various therapeutic areas due to increased demand for remote care, particularly during and post the COVID-19 pandemic.

By Device Type:

• Remote Patient Monitoring Devices: This category is experiencing the fastest growth due to increasing adoption in various healthcare settings.
• Blood Glucose Monitors: This remains a substantial segment driven by the large diabetic population.

By Stakeholder:

• Healthcare Providers: Hospitals and clinics are major adopters driving significant market demand for reliable mHealth solutions.

Key Drivers:

• Increased investment in digital health technologies: Venture capital and private equity funding fuel the growth of innovative companies and technologies.
• Government initiatives and regulatory support: Policies promoting telehealth and remote monitoring contribute to market expansion.
• Growing awareness and adoption of telehealth services: Patient demand for convenient and accessible care fuels the sector's expansion.

The specific dominance factors for each leading segment will be analyzed in detail within the full report.

North America mHealth Device Industry Product Innovations

Recent innovations in the North America mHealth device industry include advanced sensors offering increased accuracy and data granularity, integrated platforms combining multiple monitoring functionalities, AI-powered diagnostic tools offering real-time insights, and secure cloud-based data storage and analysis capabilities. These advancements lead to enhanced patient engagement, improved clinical decision-making, and reduced healthcare costs. Unique selling propositions often focus on ease of use, data integration capabilities, and seamless connectivity with electronic health records (EHR) systems.

Propelling Factors for North America mHealth Device Industry Growth

Technological advancements, such as miniaturized sensors, improved data analytics, and advanced connectivity, are primary growth drivers. Favorable economic factors, including rising disposable incomes and increasing healthcare spending, also contribute significantly. Regulatory support, including the expansion of telehealth reimbursement policies and the approval of new mHealth devices by the FDA, further accelerates market expansion. The growing prevalence of chronic diseases, coupled with the need for effective and cost-effective healthcare solutions, fuels market demand for mHealth devices.

Obstacles in the North America mHealth Device Industry Market

Regulatory hurdles, such as FDA approval processes and data privacy regulations, pose challenges. Supply chain disruptions, particularly in the sourcing of components, can impact production and pricing. Intense competition amongst established players and new entrants creates price pressure and necessitates continuous innovation. Data security concerns and cybersecurity risks pose a significant barrier to adoption. Integration issues with existing healthcare IT infrastructure can also impede market growth.

Future Opportunities in North America mHealth Device Industry

The expansion into underserved populations, the development of AI-powered diagnostic and prognostic tools, the creation of personalized medicine solutions, and the integration of mHealth devices with wearable technology present significant opportunities. The incorporation of blockchain technology for enhanced data security and the expansion into new therapeutic areas offer substantial potential.

Major Players in the North America mHealth Device Industry Ecosystem

• MobileSmith
• Oracle (Cerner Corporation)
• Care Innovations LLC
• eClinicalWorks
• Koninklijke Philips N V
• Cisco Systems Inc
• Veradigm (Allscripts Healthcare LLC)
• Medtronic PLC
• Boston Scientific Corporation
• Telus Health
• AT&T Inc
• Apple Inc
• Samsung Healthcare Solutions

Key Developments in North America mHealth Device Industry Industry

• July 2022: AmerisourceBergen launched DTx Connect, a platform facilitating patient access to digital therapeutics and diagnostics (DTx). This signals a significant shift towards integrated care models and the expansion of DTx within the mHealth landscape.
• May 2022: The University of Virginia (UVA) Health launched the HOPE app for accessible remote patient care, highlighting the increasing role of mobile apps in delivering healthcare services.

Strategic North America mHealth Device Industry Market Forecast

The North American mHealth device market is poised for continued robust growth throughout the forecast period (2025-2033), driven by technological innovations, increasing demand for remote patient care, and favorable regulatory environments. Emerging technologies such as AI and machine learning will enhance the capabilities of mHealth devices, leading to improved diagnostics, personalized treatment plans, and more effective disease management. The market's expansion will be further propelled by rising healthcare costs and the increasing adoption of value-based care models. The potential for expansion into new therapeutic areas, as well as integrating mHealth with other healthcare technologies, presents significant opportunities for market growth.

North America mHealth Device Industry Segmentation

• 1. Service Type
  • 1.1. Treatment Services
    • 1.1.1. Independent Aging Solutions
    • 1.1.2. Chronic Disease Management
  • 1.2. Diagnostic Services
  • 1.3. Monitoring Services
    • 1.3.1. Remote Patient Monitoring Devices
    • 1.3.2. Medical
    • 1.3.3. Telemedicine Solutions
    • 1.3.4. Post Acute Care Services
  • 1.4. Wellness and Fitness Solutions
  • 1.5. Other Services
• 2. Device Type
  • 2.1. Blood Glucose Monitors
  • 2.2. Cardiac Monitors
  • 2.3. Hemodynamic Monitors
  • 2.4. Neurological Monitors
  • 2.5. Respiratory Monitors
  • 2.6. Body and Temperature Monitors
  • 2.7. Remote Patient Monitoring Devices
  • 2.8. Other Device Types
• 3. Stake Holder
  • 3.1. Mobile Operators
  • 3.2. Healthcare Providers
  • 3.3. Application/Content Players
• 4. Geography
  • 4.1. United States
  • 4.2. Canada
  • 4.3. Mexico

North America mHealth Device Industry Segmentation By Geography

• 1. United States
• 2. Canada
• 3. Mexico