Intended Use

EchoSolv AS is a machine learning (ML) and artificial intelligence (AI) based decision support software indicated for use as an adjunct to echocardiography for assessment of severe aortic stenosis (AS). When utilized by an interpreting physician, this device provides information to facilitate rendering an accurate diagnosis of AS.

Technology

EchoSolv AS is a standalone, cloud-based software that analyzes patient demographic and transthoracic echocardiogram measurement data using a proprietary AI algorithm providing categorical risk probability of severe AS phenotype and guideline-based assessments, assisting board-certified cardiologists in clinical diagnosis.

Performance

Software verification and validation was performed per FDA guidance. Standalone performance testing on 6,268 studies showed an AUROC of 0.948 with consistent performance across subgroups. Clinical testing with five cardiologist readers on 200 TTE studies showed improved diagnostic performance with EchoSolv AS assistance (AUROC improved from 0.865 to 0.883).

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    5/3/2024

    5 months
  • 2

    FDA Approval

    10/4/2024

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