EKO.AI PTE. LTD.

GUDID#

Us2.ca - Us2.ca processes acquired transthoracic cardiac ultrasound images to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners in their diagnosis of cardiac amyloidosis. Us2.ca is intended for use only in adult patients with increased left ventricular wall thickness, defined as an interventricular septal thickness (IVSd) or left ventricular posterior wall thickness (LVPWd) > 12mm. Us2.ca is not intended to provide a diagnosis and does not replace current standards of care. Theresults from Us2.ca are not intended to exclude the need for further follow-up on cardiac amyloidosis.
EKO.AI PTE. LTD.
2026-04-20
Us2.v2 - Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients.Please note the following limitations: • Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality.• Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and makeappropriate clinical decisions.• If no gender is present, female referenced guideline values will be used for conclusions.• If Body Surface Area (BSA) is not present, indexed values cannot be provided.• During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack ofelectrocardiogram capture may lead to lower accuracy of the software.
EKO.AI PTE. LTD.
2024-04-22
Us2.v1 - Us2.v1 is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease and/or intra-cardiac lesions (e.g tumors, thrombi). Please note the following limitations: - Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. - Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. - If no gender is present, female referenced guideline values will be used for conclusions. - If Body Surface Area (BSA) is not present, indexed values cannot be provided. - During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
EKO.AI PTE. LTD.
2022-11-16