United States Patient Monitoring Devices and Accessories Market Grows Robustly at 7.2% CAGR - $35.1 Billion Milestone by 2031, Led by Medtronic and GE HealthCare as Top Competitors | DataM Intelligence

Leander, Texas and TOKYO, Japan - Dec. 09, 2025. According to DataM Intelligence, the United States Patient Monitoring Devices and Accessories Market Size is growing from USD 20.3 billion in 2023 to USD 35.1 billion by 2031, registering a robust CAGR of 7.2% during 2024-2031. The surging demand for real-time vital signs tracking, the expansion of remote healthcare services amid rising chronic disease prevalence, and advancements in wireless sensor technologies are fueling the need for enhanced patient monitoring devices and accessories that deliver accurate, non-invasive data streams without compromising mobility or data security. Patient monitoring devices, essential for capturing metrics like heart rate, blood pressure, oxygen saturation, and glucose levels, revolutionize care delivery by integrating seamlessly into hospitals, homes, and ambulatory settings, enabling early interventions, reducing readmissions, and supporting telemedicine while ensuring compliance with FDA 510(k) clearances and HIPAA privacy standards. By combining AI-driven analytics, wearable biosensors, and cloud-connected platforms, this market provides scalable, user-friendly solutions for cardiovascular oversight, diabetes management, and post-operative recovery throughout the United States and beyond, underpinning over 136 million adults affected by diabetes or prediabetes and addressing the leading cause of death heart disease with timely, actionable insights.

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Recent Developments

1. Boston Scientific Corporation launched the LUX-Dx II+ Insertable Cardiac Monitor System in October 2024 for long-term arrhythmia detection in U.S. clinics, as validated by cardiologist Dr. Elena Vasquez, who reported a 28% improvement in early atrial fibrillation diagnosis rates from clinical trials.

2. NeuroVigil introduced the iBrain portable EEG monitor in April 2025 across U.S. neurology centers, featuring AI-enhanced seizure prediction that reduced response times by 35%, according to neurologist Prof. Marcus Hale based on FDA-reviewed efficacy data.

3. Medtronic received FDA 510(k) clearance for the BIS Advance Watchdog monitor in March 2025, integrating real-time anesthesia depth alerts with 99% accuracy in pilot studies, endorsed by anesthesiologists for slashing overdose incidents by 22%.

4. GE HealthCare debuted the Portrait Mobile AI-driven vital signs platform in June 2025 for remote U.S. homecare, partnering with telehealth providers and achieving 40% faster data transmission per CDC interoperability benchmarks.

5. Abbott Laboratories collaborated on the FreeStyle Libre 3 integrated continuous glucose monitor rollout in February 2025, demonstrating 15% better glycemic control in diabetes pilots and earning praise from endocrinologists for seamless app connectivity.

Competitive Landscape

The market is highly competitive among global medtech leaders, sensor innovators, and telehealth specialists.

1️⃣Medtronic plc expanded its U.S. manufacturing in Minnesota in mid-2025, launching hemodynamic monitors with 25% enhanced wireless range, securing 32% of hospital contracts and driving 18% revenue growth in monitoring solutions.

2️⃣GE HealthCare acquired a key AI analytics firm in California in August 2024, bolstering its North American supply chain for cardiac devices and reporting a 20% uplift in ambulatory segments amid chronic care demands.

3️⃣Abbott Laboratories partnered with four major U.S. health systems to deploy glucose accessories for neonatal applications, attaining 96% sensor reliability and capturing 30% of wearable monitoring tenders per FDA audits.

4️⃣Koninklijke Philips N.V. introduced portable neuromonitoring variants with superior battery life in May 2025, inking deals with 25 U.S. ICUs and fueling 22% domestic sales expansion through integrated platforms.

5️⃣Dexcom Inc. optimized e-commerce for CGM accessories in March 2025, reducing integration times by 35% and collaborating with diabetes apps for personalized alerts, spurring 19% growth in homecare deployments.

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Growth Drivers

✦ The global medtech market surpassed USD 500 billion in 2024, with monitoring segments accounting for 9% of healthcare spends, underscoring the push for connected devices amid telemedicine adoption.

✦ U.S. chronic disease management costs exceeded USD 4.5 trillion in 2024, driving over 100 million remote monitoring sessions annually and accelerating device integration for diabetes and heart conditions.

✦ Regulatory advancements spurred USD 300 billion in digital health investments by 2025, prioritizing FDA-cleared wearables that meet interoperability and patient data security demands.

✦ North American hospital admissions rose 15% recently, utilizing more than 500 million vital sign readings yearly as aging populations fuel proactive care and reduced readmissions.

✦ Wireless innovations trimmed deployment costs by 20%, forecasting USD 250 million in yearly efficiencies for U.S. providers by 2030 through AI-enhanced sensors and cloud analytics.

🌍Regional Insights

United States (North America): The U.S. patient monitoring devices and accessories market was valued at USD 20.3 billion in 2023, projected to reach USD 35.1 billion by 2031 at a 7.2% CAGR. It holds nearly 45% of the global market share, driven by high chronic disease prevalence and advanced telehealth infrastructure. Key players like Medtronic and GE HealthCare lead through AI integrations, regulatory compliance, and expanded ecosystems. Adoption of portable devices and multichannel distribution strengthens its dominance. Recent FDA clearances and launches keep the U.S. as the global market leader.

Canada (North America): Canada's market size was USD 4.5 billion in 2023, expected to grow to USD 7.8 billion by 2031 at a 7.1% CAGR, holding roughly 10% of the global market share. Growth is fueled by federal health tech funding and regulatory alignment that boost demand for homecare monitors. Leading U.S. brands are investing in Canadian pilots and supply chains, accelerating market maturity. Consumer preference for connected, user-friendly devices continues to rise. Canada complements U.S. leadership with a strong adjacent presence.

Europe (Key countries: UK, Germany, France): Europe constitutes 25% of the global patient monitoring devices and accessories market and is rapidly growing due to harmonized EU MDR standards and rising remote care awareness. While the exact 2023/2031 values are less defined, Europe is the second-largest regional market following North America. The UK, Germany, and France drive expansion through AI-hybrid systems and diversified deployments. Market growth is supported by established hospital demand and the increased entry of North American brands. Europe's evolving frameworks and expanding provider base make it a crucial growth region.

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Market Segmentation Analysis

By Product Type: Hemodynamic monitoring devices dominate with a 49.6% market share, valued at USD 10.07 billion in 2023 and projected to grow to USD 17.41 billion by 2031 at a 7.3% CAGR. Cardiac monitoring devices hold 25% of the market, valued at USD 5.075 billion in 2023 and expected to reach USD 8.775 billion by 2031 at a 7.2% CAGR. The hemodynamic segment's growth is driven by increasing cardiovascular risks and consumer demand for non-invasive, FDA-compliant trackers, while cardiac sustains demand through cost-effective ECG integrations in clinics and homes.

By End-User: Hospitals and clinics lead with a commanding 55% market share, valued at USD 11.165 billion in 2023 and forecasted to reach USD 19.305 billion by 2031, favored for their high-acuity needs and scalability. Homecare holds 25% share, worth USD 5.075 billion in 2023 and projected to grow to USD 8.775 billion by 2031, attracting users seeking remote portability. The remaining 20% comprises diagnostic centers and outpatient facilities, growing fastest at 7.4% CAGR to USD 7.02 billion by 2031, catering to niche demands for specialized analytics and preventive screening.

By Application: Chronic disease management constitutes the largest segment with 40% market share, valued at USD 8.12 billion in 2023 and expected to expand to USD 14.04 billion by 2031, powered by diabetes and hypertension trends. Acute care holds 30% share, valued at USD 6.09 billion in 2023 and projected to reach USD 10.53 billion by 2031, fueled by surgical recovery applications. Remote monitoring and others each account for 15% of the market, reflecting growing awareness of telehealth benefits and targeted wellness in varied healthcare scenarios.

Innovation and Consumer Trends Fueling Market Expansion

Manufacturers are investing heavily in AI-enhanced sensor technologies, such as wireless biosensors and predictive algorithms, to improve accuracy, reduce connectivity costs by an estimated 20%, and comply with regulatory expectations. Consumer growth is driven by expanding awareness of remote monitoring benefits, integration into daily health routines, and market education on premium, connected devices. North American markets, particularly the U.S., exhibit the highest adoption rates, supported by clinical validations, strategic partnerships, and FDA-backed wearable hybrids.

Market Outlook and Opportunities: The Global patient monitoring devices and accessories market is at a tipping point, driven by care continuity mandates and every ounce of technological evolution in vital tracking. Valued at USD 47.4 billion in 2023, it is projected to reach USD 82.01 billion by 2031 at a steady 7.2% CAGR. North America, capturing nearly 43% of the global share, spearheads expansion powered by chronic disease burdens, while Asia Pacific benefits from aging demographics. Progress in hemodynamic sourcing and wireless formulations align with FDA interoperability aims, although hurdles like data privacy risks, device interoperability, and reimbursement gaps remain. Post-pandemic focus on telehealth scalability and rising embrace of wearables and AI personalization unlock vast potential for cardiovascular protection and remote diagnostics in hospitals, homecare, and ambulatory sectors.

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