AUSTIN, Texas and TOKYO, Nov. 24, 2025 /PRNewswire/ — According to DataM Intelligence, the U.S. Software as a Medical Device (SaMD) Market Size reached USD 205.12 million in 2024 and is forecast to climb to USD 715.00 million by 2033, expanding at a strong CAGR of 13.5% during the forecast period 2025–2033. This rapid growth reflects a fundamental shift toward AI-powered clinical decision support, digital diagnostics, virtual care delivery, and algorithm-driven disease management solutions.

The Software as a Medical Device ecosystem-software intended for medical use without being integrated into a physical device-has gained momentum as healthcare systems undergo digital transformation. AI algorithms, mobile applications, data-driven diagnostics, predictive analytics, and continuous monitoring platforms are now central to U.S. healthcare delivery, fueled by increasing chronic disease burden, provider shortages, and demand for real-time, personalized care.

From AI-based triage tools to remote cardiac monitoring and digital diabetes management platforms, SaMD is reshaping the care continuum, improving patient outcomes, and strengthening clinical efficiency across hospitals, ambulatory centers, and home-care settings.

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Market Overview: AI, FDA Guidance & Hospital Digitalization Drive Demand

The U.S. is one of the fastest-growing Software as a Medical Device markets globally due to several structural drivers:

Clearer FDA regulatory pathways, including the Pre-Cert Program, 510(k) expansion, and clinical evaluation guidelines for AI/ML-based SaMD.
Surging chronic disease cases, especially diabetes, cardiovascular diseases, mental health disorders, and oncology.
Hospital automation & digital-first care, where AI triage, imaging analysis, and remote monitoring reduce clinician burden.
Integration of SaMD with wearables, CGMs, ECG patches, biosensors, and smartphones, enabling continuous diagnostics.
35% increase in digital therapeutic use among U.S. payers, enhancing reimbursement traction.
Shift toward predictive health, where SaMD platforms analyze physiological and behavioral data to prevent disease progression.

Market Segmentation Analysis

By Application (Disease Management, Diagnostics, Treatment Monitoring, Predictive Health Analytics, Others)

Disease Management

Disease management was the largest application area in 2024, contributing nearly 38% of market revenue, or approximately USD 78 million. SaMD platforms are now widely used for diabetes management, mental health support, COPD monitoring, and cardiovascular risk reduction. AI-driven behavioral coaching, glucose trend analysis, and symptom tracking are core capabilities enabling personalized interventions and reducing hospitalizations.

Diagnostics

Diagnostics accounted for 29% of the market, valued at USD 59 million. AI-based imaging analytics, digital pathology platforms, ophthalmology screening tools, and virtual ECG diagnostic engines are gaining strong adoption among U.S. hospitals. FDA-cleared AI diagnostic tools, especially in stroke detection (e.g., Viz.ai), have become critical for reducing time-to-treatment and improving outcomes.

Treatment Monitoring

Treatment monitoring represented 20% of the market value (USD 41 million). SaMD platforms track medication adherence, vitals, wound recovery, therapy response, and patient-reported outcomes. Oncology treatment monitoring systems and heart failure progression trackers are expanding rapidly due to increasing value-based care initiatives.

Predictive Health Analytics

Predictive health analytics accounted for 10% (USD 20 million). These platforms analyze physiological datasets, lifestyle patterns, and biomarker trends to predict exacerbations, support preventive care, and optimize patient triage. Adoption is expected to grow significantly as insurers increasingly reimburse preventive digital health tools.

By Indication (Diabetes, Mental Health, Oncology, Cardiovascular, Respiratory Conditions, Others)

Diabetes

Diabetes was the leading indication in 2024, accounting for 32% of SaMD demand, equal to USD 65 million. Integration between SaMD and continuous glucose monitors (CGMs), insulin pens, and insulin pumps continues to drive adoption, especially among Type I and insulin-dependent Type II patients. AI-supported glycemic prediction algorithms saw double-digit growth across U.S. clinics.

Mental Health

Mental health applications contributed 22% (USD 45 million). Digital therapeutics for depression, anxiety, and behavioral health management are increasingly prescribed by clinicians, supported by strong payer engagement and rising mental health awareness nationwide.

Cardiovascular Diseases

Cardiovascular indications accounted for 19% (USD 39 million). SaMD platforms detecting atrial fibrillation, monitoring arrhythmias, and predicting cardiac events have seen rapid uptake, driven by rising heart disease prevalence and integration with ECG wearables.

Oncology

Oncology-focused Software as a medical device systems represented 14% (USD 29 million). Digital tumor progression trackers, AI-driven radiology engines, and symptom-monitoring apps help oncologists adjust treatment plans proactively and improve the quality of life for cancer patients.

Respiratory Conditions

Respiratory conditions contributed 9% (USD 18 million). Software as a Medical Device tools for COPD monitoring, asthma management, and sleep disorder detection are expanding rapidly due to the increasing prevalence of chronic lung diseases.

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U.S. Market Trends: Regulatory Advancements & Hospital Digitization Accelerate Adoption

The U.S. Software as a Medical Device landscape benefited from strong regulatory and commercial developments in the past year:

The FDA’s updated AI/ML SaMD Action Plan increased transparency and accelerated clearance review cycles.
Hospitals increased AI diagnostic deployment by 27% YoY, especially for imaging and emergency care.
Mental-health SaMD prescriptions grew 34% YoY, driven by high post-pandemic demand.
SaMD integrated with wearable devices recorded 41% adoption growth across primary care settings.
U.S. health insurers expanded coverage for digital diabetes and cardiac monitoring programs, improving patient access.
Nearly 65% of U.S. health systems now use at least one FDA-cleared AI medical software tool.

Competitive Landscape: Key Innovators Driving Software as a Medical Device Growth

The market includes AI-health tech leaders, digital therapeutic developers, remote monitoring companies, and global medical device manufacturers advancing regulated medical software.

Key Market Players Include:

Viz.ai, Inc. – Leader in AI stroke detection & imaging-based emergency diagnostics
Medtronic Plc – Strong portfolio of cardiac monitoring & diabetes software solutions
AliveCor – Pioneer in FDA-cleared mobile ECG diagnostics
Empatica – Known for seizure detection & wearable-integrated SaMD platforms
Bigfoot Biomedical – Integrated diabetes insulin decision-support systems
Digital Diagnostics Inc. – Leading AI diagnostic company for ophthalmology
Imagen – AI-powered radiology diagnostics
Orthogonal – Specialized SaMD development & compliance engineering

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Future Outlook: Software as a Medical Device Will Become the Backbone of Digital-First Healthcare in the U.S.

By 2033, the Software as a Medical Device Market will evolve toward:

AI-first clinical decision support systems integrated across all specialties
Predictive-care engines that anticipate disease exacerbations before symptoms occur
Digital therapeutic-centric care models for chronic disease management
Greater integration with implantable and wearable medical devices
Remote hospital-at-home models supported by Software as a Medical Device platforms
Dynamic regulatory pathways for self-evolving AI algorithms
Enterprise-wide SaMD interoperability across EHRs and payer systems

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