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 Heart Failure 2.0 is an automated machine learning-based decision support system, indicated as a diagnostic aid for patients undergoing routine functional cardiovascular assessment using echocardiography to detect heart failure with preserved ejection fraction (HFpEF).
EchoGo Heart Failure 2.0 processes 2D echocardiogram apical four-chamber view images using a convolutional neural network AI model to produce a classification indicating presence or absence of HFpEF, along with a confidence score and comparative histogram versus population data. It operates fully automated, interfacing via APIs and hosted on cloud or third-party infrastructure.
Performance testing included software verification and validation with unit, module, and system tests, cybersecurity and usability evaluations, and clinical validation across 1578 patients from multiple clinical sites. The device demonstrated high sensitivity (~90%) and specificity (~86%) for HFpEF detection, excellent repeatability, and meeting all safety and effectiveness requirements for substantial equivalence.
No predicate devices specified
Submission
1/2/2024
FDA Approval
9/23/2024
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