Market Segmentation

By Function / Software Type

• Diagnostic SaMD (Software that identifies disease/conditions (e.g., image analysis, pattern recognition).
• Monitoring & Remote Patient Monitoring (RPM) SaMD (Continuous or periodic monitoring of vitals, biomarkers, adherence)
• Clinical Decision Support (CDS) SaMD (Decision aids for clinicians (risk scores, triage).
• Therapeutic / Digital Therapeutics (DTx) SaMD (Software that delivers therapy (behavioral, rehabilitative).
• Workflow & Operational SaMD (Scheduling, image routing, AI triage, reporting automation)

By Application / Therapeutic Area

• Radiology / Imaging (CT, MRI, X-ray)
• Cardiology (ECG analysis, Echo Interpretation)
• Neurology (Stroke, EEG analysis)
• Oncology (Tumor Detection, Progression Tracking)
• Endocrinology / Diabetes (Glucose Monitoring Analytics)
• Respiratory (COPD, Asthma)
• Mental Health (Assessment, CBT delivery)
• Infectious Diseases / Sepsis Prediction
• Others

By Regulatory Class / Risk Level

• Low-to-Moderate Risk (e.g., CDS, Non-diagnostic tools)
• High Risk (Diagnostic/therapeutic decision makers)
• Adaptive AI/ML SaMD

By Deployment Model

• Cloud-hosted / SaaS (Multi-tenant, Central Updates)
• On-premise / Edge (Data privacy / Latency sensitive)
• Hybrid

By Technology Stack / Capability

• AI/ML-enabled (deep learning, classical ML)
• Rule-based / Algorithmic
• Connected (IoT + wearables)
• Blockchain / Secure Audit-trail features

By End-User / Buyer Persona

• Hospitals & Health Systems
• Clinics / Ambulatory Care
• Payers / Insurance
• Patients / Consumers
• Diagnostic Labs / Imaging Centers
• Government / Public Health Agencies

By Distribution Channel

• Direct sales (enterprise sales teams)
• OEM / Embedded (software bundled with medical devices)
• Partnerships with EMR vendors / system integrators
• Marketplaces / App ecosystems (EHR app stores)

By Region

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