EchoGo - FDA-Cleared AI Echocardiography Analysis Platform

Ultromics EchoGo – FDA-Cleared AI Platform for Automated Echocardiography Analysis

Ultromics EchoGo AI Echocardiography Analysis revolutionizes cardiac imaging through FDA-cleared artificial intelligence that automates echocardiogram interpretation, delivering structured, reproducible reports in under 20 minutes. This cloud-based platform addresses critical challenges in echocardiography—interpretation variability, time-intensive manual measurements, and workflow bottlenecks—while enabling earlier detection of complex cardiac conditions including heart failure with preserved ejection fraction (HFpEF) and cardiac amyloidosis.

The Echocardiography Challenge

Echocardiography is the most commonly performed cardiac imaging modality, with over 30 million studies annually in the US alone. Despite its clinical value, echo interpretation faces significant challenges:

• Inter-observer variability: Manual measurements of ejection fraction vary by 10-15% between readers
• Time-intensive analysis: Comprehensive echo interpretation requires 30-60 minutes of physician time
• Subtle disease detection: Early HFpEF and cardiac amyloidosis are notoriously difficult to identify
• Workforce shortages: Limited availability of expert echocardiographers creates interpretation backlogs
• Inconsistent protocols: Variable measurement techniques reduce longitudinal tracking reliability

These limitations result in delayed diagnoses, inconsistent treatment decisions, and preventable morbidity. EchoGo addresses these systemic gaps through validated AI automation.

How EchoGo Works

Automated Image Analysis

EchoGo processes standard transthoracic echocardiogram DICOM files through sophisticated deep learning algorithms:

• View Classification: Automatically identifies and labels echocardiographic views (apical 4-chamber, parasternal long-axis, etc.)
• Cardiac Cycle Detection: Identifies end-diastole and end-systole frames for accurate measurement
• Left Ventricle Segmentation: Precisely delineates endocardial and epicardial borders across cardiac phases
• Quality Assessment: Flags suboptimal images requiring repeat acquisition

This automated preprocessing eliminates manual frame selection and border tracing—the most time-consuming aspects of echo interpretation.

Comprehensive Quantitative Measurements

EchoGo calculates critical cardiac function parameters with precision exceeding manual techniques:

• Left Ventricular Ejection Fraction (LVEF): Gold-standard measure of systolic function
• End-Diastolic Volume (EDV) and End-Systolic Volume (ESV): Chamber size quantification
• Global Longitudinal Strain (GLS): Sensitive marker of early myocardial dysfunction
• Segmental Strain Analysis: Regional function assessment identifying focal abnormalities
• Diastolic Function Parameters: Evaluation of heart failure with preserved ejection fraction

These measurements follow American Society of Echocardiography (ASE) guidelines, ensuring clinical validity and comparability.

Structured Reporting

Within 20 minutes of upload, EchoGo generates comprehensive reports including:

• Quantitative measurements with normal reference ranges
• Automated interpretative text
• Visual strain mapping and bull’s-eye plots
• Comparison with prior studies when available
• DICOM-compliant format for PACS integration

Specialized Disease Detection

EchoGo Core: Comprehensive left ventricular function analysis for general cardiology applications including heart failure assessment, cardiomyopathy evaluation, and pre/post-chemotherapy cardiac monitoring.

EchoGo Amyloidosis: FDA-cleared breakthrough device specifically designed for cardiac amyloidosis screening—a frequently missed diagnosis with devastating consequences if untreated. The AI identifies characteristic strain patterns (apical sparing) and other subtle features indicating amyloid infiltration, enabling earlier diagnosis when disease-modifying therapies are most effective.

Clinical Validation

FDA 510(k) Clearance: EchoGo Core 2.0 and EchoGo Amyloidosis have received rigorous FDA clearance, demonstrating equivalence to expert manual interpretation.

Multicenter Validation Studies:

• Excellent correlation with manual measurements (r>0.90 for LVEF, volumes)
• Reduced inter-observer variability by 50-60% compared to manual techniques
• High sensitivity and specificity for cardiac amyloidosis detection
• Reproducibility exceeding human readers across diverse patient populations and image quality

Real-World Performance: Deployment across academic medical centers and community hospitals demonstrates consistent accuracy across operator skill levels and equipment manufacturers.

Clinical Benefits

Time Efficiency: Automating measurements reduces cardiologist interpretation time by 40-50%, enabling higher throughput without compromising quality.

Diagnostic Consistency: Standardized AI analysis eliminates inter-observer variability, supporting reliable treatment decisions and longitudinal tracking.

Earlier Disease Detection: Sensitive strain analysis identifies subclinical dysfunction before ejection fraction declines, enabling earlier intervention.

Cardiac Amyloidosis Screening: Systematic amyloid screening prevents missed diagnoses—particularly important as effective therapies now exist for this previously untreatable condition.

Workforce Optimization: AI handles routine measurements, allowing cardiologists to focus expertise on complex integration and clinical decision-making.

Quality Assurance: Automated compliance with ASE guidelines ensures consistent adherence to best practices.

Implementation

Cloud-Based SaaS Model: No on-site hardware installation required. Hospitals upload DICOM files to secure cloud platform for processing.

PACS Integration: Reports return as DICOM structured reports, integrating seamlessly with existing cardiology information systems.

Security & Compliance: HIPAA-compliant infrastructure with enterprise-grade encryption and access controls.

Scalability: Handles institutional volumes from small cardiology practices to large academic centers.

Training: Minimal learning curve—physicians review AI-generated reports rather than performing manual measurements.

Use Cases

• General cardiology practices: Comprehensive echo interpretation for heart failure, valvular disease, cardiomyopathy
• Heart failure clinics: Serial monitoring of ejection fraction and strain
• Oncology cardiology: Chemotherapy cardiotoxicity surveillance
• Amyloidosis centers: Systematic screening of at-risk populations
• Research studies: Standardized core lab analysis for clinical trials

Who Should Adopt EchoGo

• Hospital cardiology departments managing high echo volumes
• Outpatient imaging centers seeking workflow efficiency
• Academic medical centers requiring reproducible research measurements
• Practices with amyloidosis programs needing systematic screening
• Community hospitals lacking on-site echo expertise

Pricing & ROI

Cloud-based subscription model with per-study or monthly fees. ROI achieved through increased throughput, reduced physician time, improved diagnostic accuracy, and enhanced amyloidosis detection enabling high-value therapy initiation.

Conclusion

Ultromics EchoGo transforms echocardiography from variable, labor-intensive interpretation into standardized, efficient, AI-powered analysis. With FDA clearance, proven accuracy, and specialized capabilities for challenging diagnoses like cardiac amyloidosis, EchoGo represents the future of cardiac imaging—delivering cardiologist-level interpretation at scale while freeing physicians to focus on clinical integration and patient care.