Executive Summary
Cardio AI delivers a comprehensive, AI-powered cardiovascular diagnostic platform featuring 10+ advanced machine learning models, unified clinical decision support, enterprise-grade security, and seamless healthcare IT integration. Our platform transforms cardiovascular care delivery through evidence-based risk assessment, intelligent diagnostics, and real-time clinical insights.
Core Platform Capabilities
1. CVD Risk Assessment Suite
🫀 AMI Risk Calculator
Purpose: Acute Myocardial Infarction prediction
Accuracy: ≥0.80
Input: Clinical data, biomarkers, patient history
Output: Risk score, time-to-event prediction, recommendations
🧠 Stroke Risk Calculator
Purpose: Ischemic & hemorrhagic stroke prediction
Accuracy: ≥0.78
Input: Cardiovascular risk factors, imaging data
Output: Stratified risk assessment, prevention strategies
💓 Heart Failure Predictor
Purpose: HF onset and progression prediction
Accuracy: ≥0.79
Input: Echo data, biomarkers, functional status
Output: Risk classification, trajectory modeling
⚡ SCD Risk Calculator
Purpose: Sudden Cardiac Death risk assessment
Accuracy: ≥0.78
Input: ECG data, genetic factors, family history
Output: Risk quantification, ICD candidacy
💫 AFib Risk Predictor
Purpose: Atrial Fibrillation development prediction
Accuracy: ≥0.78
Input: ECG, structural heart data, comorbidities
Output: Incident AFib probability, monitoring recommendations
2. AI Diagnostic Agents
🔬 Arrhythmia Detection Agent
Function: Real-time ECG analysis and arrhythmia classification
Coverage: 20+ arrhythmia types including AFib, VT, VF, AV blocks
Technology: Deep CNN with temporal analysis
Validation: Multi-site clinical trials ongoing
💚 Heart Failure Diagnostic Agent
Function: HF detection, classification (HFrEF/HFpEF), severity staging
Integration: Echo, biomarkers, clinical data fusion
Technology: Multi-modal deep learning
Output: NYHA class, ejection fraction estimation
🩺 CAD Analysis Agent
Function: Coronary artery disease detection and quantification
Imaging: CT angiography, stress testing integration
Technology: 3D convolutional networks
Output: CAD-RADS scoring, stenosis quantification
🫁 Cardiomyopathy Assessment Agent
Function: Identification and classification of cardiomyopathies
Types: Dilated, hypertrophic, restrictive, arrhythmogenic
Technology: Multi-parameter analysis with genetic correlation
Output: Type classification, disease progression tracking
🚨 STEMI Detection Agent
Function: Rapid ST-elevation myocardial infarction detection
Speed: <10 seconds from ECG acquisition
Technology: Real-time deep learning with alert system
Integration: EHR auto-notification, cath lab activation protocol
3. Master Orchestrator Platform
Unified Clinical Decision Support System
The Master Orchestrator serves as the central nervous system of our platform, intelligently coordinating all AI models, data streams, and clinical workflows into a seamless, unified experience.
- Centralized Data Management: Single source of truth for all patient cardiovascular data
- Real-Time AI Orchestration: Intelligent routing of data to appropriate models
- Workflow Optimization: Automated clinical pathways based on risk scores and diagnoses
- Multi-Source Integration: EHR, IoMT, PACS, lab systems unified interface
- Customizable Dashboards: Role-based views for cardiologists, nurses, administrators
- Advanced Analytics: Population health insights, quality metrics, outcomes tracking
- Alert Management: Intelligent prioritization of clinical alerts to reduce alarm fatigue
- Care Coordination: Cross-team communication and task management
4. IoMT Integration Platform
Comprehensive remote patient monitoring through wearable devices and medical IoT integration.
| Device Category | Supported Devices | Data Collected | Update Frequency |
|---|---|---|---|
| Consumer Wearables | Apple Watch, Fitbit, Garmin | HR, HRV, Activity, Sleep, ECG | Real-time / Continuous |
| BP Monitors | Omron, Withings, iHealth | Systolic/Diastolic BP, Pulse | Per measurement |
| ECG Devices | KardiaMobile, AliveCor | 12-lead equivalent ECG | On-demand / Scheduled |
| Weight Scales | Withings, Fitbit Aria | Weight, BMI, Body composition | Daily |
| Glucose Monitors | Dexcom, FreeStyle Libre | Continuous glucose | Every 5 minutes |
Data Streaming: MQTT and Kafka protocols for real-time data ingestion with sub-second latency
Alert Generation: Automated threshold-based and AI-driven anomaly detection
Patient Portal: Mobile app for patients to view trends and receive guidance
5. PACS/DICOM Integration
Advanced medical imaging analysis with AI-powered diagnostic support for cardiac imaging studies.
- Modality Support: Cardiac CT, MRI, Echocardiography, X-Ray, Nuclear imaging
- DICOM Compliance: ISO 12052 standard, full DICOM SR support
- Automated Workflows: Image routing, hanging protocols, post-processing
- AI Analysis: Automated measurements, abnormality detection, quantification
- 3D Visualization: Multi-planar reconstruction, volume rendering, cinematic display
- Reporting: Structured reporting templates, voice dictation integration
- Archive Integration: VNA connectivity, cloud PACS support
- FHIR/HL7: Standards-compliant data exchange with EHR systems
6. Women's Health Cardiology
Specialized obstetric cardiology platform addressing pregnancy-specific cardiovascular risks.
🤰 Pregnancy Risk Assessment
Comprehensive cardiovascular risk evaluation across all three trimesters with trimester-specific algorithms
💊 Preeclampsia Prediction
Early detection models using biomarkers, BP trends, and clinical factors with ≥0.85 accuracy
📊 Gestational Hypertension
Continuous monitoring and risk stratification for pregnancy-induced hypertension
💝 Peripartum Cardiomyopathy
Detection and management of PPCM with echo-guided algorithms
👶 Maternal-Fetal Risk
Integrated risk assessment for both maternal and fetal cardiovascular outcomes
📈 Outcome Prediction
Post-delivery cardiovascular risk and long-term prognosis modeling
Market Opportunity: $500 billion maternal healthcare market
Clinical Need: Addressing rising maternal mortality rates due to cardiovascular complications
Unique Value: First comprehensive AI platform specifically designed for pregnancy-related cardiovascular care
Technical Specifications
Platform Architecture
| Component | Technology | Specification |
|---|---|---|
| Infrastructure | Cloud-Native | AWS/Azure/GCP with multi-region deployment |
| Scalability | Microservices | Kubernetes orchestration, auto-scaling |
| Database | Hybrid | PostgreSQL (structured), MongoDB (unstructured), Redis (cache) |
| AI Framework | PyTorch/TensorFlow | GPU-accelerated inference, model versioning |
| API | RESTful + GraphQL | OAuth 2.0, rate limiting, comprehensive documentation |
| Messaging | MQTT, Kafka | Real-time streaming, event-driven architecture |
| Availability | High Availability | 99.9% uptime SLA, redundant systems |
AI Model Performance
| Model | Accuracy (AUC-ROC) | Training Data | Validation |
|---|---|---|---|
| AMI Risk Calculator | ≥0.80 | 500,000+ patient cohort | External validation ongoing |
| Stroke Risk Calculator | ≥0.78 | 350,000+ patient cohort | Multi-site trials |
| Heart Failure Predictor | ≥0.79 | 400,000+ patient cohort | Prospective validation |
| SCD Risk Calculator | ≥0.78 | 200,000+ patient cohort | Clinical trials in progress |
| AFib Predictor | ≥0.78 | 450,000+ patient cohort | External validation |
Security & Compliance
| Security Control | Implementation |
|---|---|
| Data Encryption | AES-256 at rest, TLS 1.3 in transit |
| Key Management | Hardware Security Module (HSM), automated rotation |
| Access Control | Mandatory MFA, RBAC, automatic session timeouts |
| Authentication | SSO (SAML 2.0), OAuth 2.0, integration with major identity providers |
| Audit Logging | Comprehensive audit trails, tamper-proof logs, 7-year retention |
| Monitoring | 24/7 Security Operations Center (SOC), real-time threat detection |
| Incident Response | 72-hour breach notification, dedicated security team |
| Data Privacy | Minimum necessary access, de-identification capabilities, patient consent management |
| Penetration Testing | Annual third-party testing, continuous vulnerability scanning |
| Identity & Access Management | Keycloak IAM, fine-grained authorization, centralized authentication |
| Quality Improvement | QIDC (Quality Improvement and Data Capture) compliant workflows |
| Clinical Guidelines Adherence | AHA, ACC, and ESC guidelines integration for evidence-based care |
| Good Clinical Practice | GCP compliant clinical research and data collection protocols |
| Software as Medical Device | FDA SaMD 2023 guidance compliance, risk-based quality management |
Integration Capabilities
EHR/EMR Systems
- Epic (HL7, FHIR R4)
- Cerner (HL7, FHIR R4)
- Allscripts (HL7, FHIR)
- Meditech (HL7)
- athenahealth (FHIR)
- Custom HL7 v2.x and FHIR integrations
Laboratory Systems
- LIS integration for troponin, BNP, CRP, lipid panels
- Automated result ingestion and trending
- Critical value alerting
Standards Compliance
- FHIR R4: Full support for cardiovascular resources
- HL7 v2.x & v3: Bidirectional messaging
- DICOM: ISO 12052 compliance, DICOM SR, WADO-RS
- IHE Profiles: XDS, PIX, PDQ
- CDA: C-CDA continuity of care documents
SSO & Identity Providers
- Okta
- Azure Active Directory
- Auth0
- Custom SAML 2.0 / OAuth 2.0 providers
Performance & Scalability
⚡ Response Time
Risk Calculators: <2 seconds
STEMI Detection: <10 seconds
Dashboard Load: <1 second
API Response: <500ms (95th percentile)
📊 Throughput
Concurrent Users: 10,000+
Transactions/sec: 100,000+
ECG Analysis: 1,000/minute
Image Processing: 500 studies/hour
🌐 Availability
Uptime SLA: 99.9%
Disaster Recovery: RPO <1 hour, RTO <4 hours
Geographic Redundancy: Multi-region deployment
📈 Scalability
Auto-Scaling: Dynamic resource allocation
Data Storage: Petabyte-scale capacity
Patient Capacity: Millions of active patients
Regulatory & Clinical Validation
FDA Regulatory Strategy
- Classification: Class II Medical Device Software
- Pathway: 510(k) clearance for diagnostic agents
- IoMT Integration: Class II device classification
- Current Status: Team working to obtain FDA and other regulatory approvals
- Quality System: ISO 13485 implementation in progress
- Clinical Evidence: Multi-site validation studies ongoing
Clinical Validation
| Validation Type | Status | Sites/Participants |
|---|---|---|
| Digital Clinical Trials | Ongoing | 5 sites, 10,000+ patients |
| External Validation | In Progress | Academic medical centers |
| Prospective Studies | Planned | Multi-national, 20,000+ patients |
| Real-World Evidence | Collection Phase | Partner healthcare systems |
Academic Partnerships
- Stanford Medicine: Algorithm development and validation
- Cornell Medical Center: Women's health cardiology research
- Harvard Medical School: Clinical outcomes research
- Collaboration Focus: Algorithm refinement, clinical validation, real-world effectiveness
Service Packages
| Feature | Starter ($40 PMPM) | Professional ($80 PMPM) | Enterprise (Custom) |
|---|---|---|---|
| Risk Calculators | 3 calculators | All 5 calculators | All 5 calculators |
| AI Diagnostic Agents | — | 3 agents | All 5 agents |
| Master Orchestrator | Basic access | Full access | Full access + customization |
| IoMT Integration | — | 2 device types | All devices |
| PACS/DICOM | — | — | Full integration |
| Women's Health Module | — | — | Included |
| Patient Capacity | Up to 500 | Up to 2,000 | Unlimited |
| Support | Email (48h) | Priority (24h) | 24/7 + Dedicated Manager |
| Training | Basic | Comprehensive | On-site + Ongoing |
| API Access | — | Standard | Full + Custom endpoints |
| Custom AI Models | — | — | Available |
| White-Label Options | — | — | Available |
Note: PMPM = Per Member Per Month. All packages include HIPAA compliance, data encryption, regular platform updates, and basic training. Volume discounts available for enterprise customers.
Implementation & Support
Implementation Process
Phase 1: Assessment (2-4 weeks)
Requirements gathering, infrastructure review, workflow analysis, solution design
Phase 2: Integration (4-8 weeks)
EHR integration, PACS connectivity, IoMT setup, system configuration, data migration
Phase 3: Training (2-4 weeks)
Clinical staff training, administrative training, super user certification, workflow optimization
Phase 4: Go-Live (1-2 weeks)
Production deployment, go-live support, performance monitoring, optimization
Training & Education
- Live Virtual Training: Interactive sessions for all user roles
- On-Site Training: Available for Enterprise customers
- CME-Accredited Courses: Continuing medical education credits
- Certification Programs: Super user and administrator certification
- Video Tutorial Library: On-demand learning resources
- Documentation: Comprehensive user guides, quick reference cards
- Ongoing Education: Regular webinars on new features and best practices
Support Services
| Support Level | Availability | Response Time | Channels |
|---|---|---|---|
| Starter | Business Hours | 48 hours | Email, Portal |
| Professional | Extended Hours | 24 hours | Email, Phone, Portal |
| Enterprise | 24/7/365 | 2 hours (Priority 1) | Email, Phone, Portal, Slack |
Ready to Transform Cardiovascular Care?
Schedule a demonstration to see how Cardio AI can enhance your cardiovascular service line
Request a Demo Contact Sales Explore Technology