Intended Use

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).

Technology

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

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.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    1/2/2024

    8 months
  • 2

    FDA Approval

    9/23/2024

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