EchoGo Core
Ultromics LtdEchoGo Core is an automated software application that processes echocardiogram images to measure cardiac function parameters such as ejection fraction, global longitudinal strain, and left ventricular volumes. It provides clinicians with quantitative reports to assist in diagnosing heart conditions, improving accuracy and reducing variability compared to manual methods.
Intended Use
EchoGo Core is intended to be used for quantification and reporting of results of cardiovascular function to support physician diagnosis in adult populations.
Technology
EchoGo Core is a standalone software that automatically analyzes echocardiogram images to measure ejection fraction, global longitudinal strain, and left ventricular volume using machine learning-based auto-contouring algorithms. It generates quantitative reports based on Simpson's biplane method without manual contour editing.
Performance
The device was validated retrospectively on 378 echocardiogram studies from multiple ultrasound systems demonstrating comparable accuracy to the predicate device TomTec Arena TTA2, with low error rates and eliminated inter-operator variability due to automated contouring. Software verification and cybersecurity testing were also conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/1/2019
6 months - 2
FDA Approval
11/13/2019
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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