EchoGo Pro
Ultromics LtdEchoGo 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.
Intended Use
EchoGo Pro v1.0.2 is a machine learning-based decision support system, indicated as an adjunct to diagnostic stress echocardiography for patients undergoing assessment for coronary artery disease (CAD). It is to be used with stress echo exam protocols containing A2C, A4C, and mid-ventricular short-axis views at rest and peak stress.
Technology
EchoGo Pro v1.0.2 is a standalone software application that uses anonymized DICOM 3.0 compliant stress echo datasets (ultrasound images) and employs automated image registration, segmentation, and analysis of the left ventricle using machine learning models to generate a categorical classification of coronary artery disease likelihood. It supports standard clinical SE views (apical 2-chamber, 4-chamber, and parasternal short-axis), requires operator approval of LV contouring, and outputs a report for clinical use. The software operates on Windows platforms using off-the-shelf hardware.
Performance
Performance testing included software verification and validation according to FDA guidance, clinical testing to evaluate diagnostic performance improvement and inter-operator agreement with EchoGo Pro compared to without assistance. The system showed statistically significant improvement in reader diagnostic performance (AUROC 0.927) and inter-operator agreement (Kendall Tau-B increase to 0.82, p<0.001), exceeding the predicate device's reported improvements. These demonstrate that EchoGo Pro is as safe and effective as the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/10/2020
6 months - 2
FDA Approval
12/18/2020
Other devices from Ultromics Ltd
- EchoGo Amyloidosis (1.0)2024 • 510K
- EchoGo Heart Failure (2.0)2024 • 510K
- EchoGo Core (2.0)2021 • 510K
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