FDA Radiology AI Devices

EchoGo Amyloidosis (1.0) is an automated AI decision support system that analyzes 2D echocardiograms (specifically apical four chamber view) to screen for cardiac amyloidosis in adults over 65 years with heart failure. It helps clinicians by classifying patients as suggestive or not suggestive of cardiac amyloidosis, enabling referral for confirmatory testing. The AI was trained on large datasets and validated clinically to ensure accuracy and safety.

EchoGo Heart Failure 2.0 is an AI-powered software tool that analyzes echocardiogram images of the heart's apical four-chamber view to support clinicians in detecting heart failure with preserved ejection fraction (HFpEF). It provides a diagnostic aid by outputting a classification and a confidence score, enhancing cardiovascular assessments and helping guide clinical decision-making.

EchoGo Pro is an AI-powered software tool designed to assist physicians in diagnosing coronary artery disease by analyzing stress echocardiography ultrasound images. It processes images acquired during stress echo exams, automatically segments the left ventricle, and uses machine learning to provide a categorical assessment of the likelihood of significant CAD, helping clinicians make more accurate and consistent diagnoses.