Medical technology company Bay Labs has announced that its EchoMD AutoEF software product has secured US Food and Drug Administration (FDA) clearance.
The FDA awarded 510(k) clearance to the EchoMD AutoEF software for complete automated clip selection and calculation of left ventricular ejection fraction (EF).
EF is one of the most widely used measurements of cardiac function from echocardiograms and helps in taking various clinical decisions.
The solution, by running algorithms, automatically assesses all the digital video clips of cardiac cycles from a patient’s echocardiography study and selects the best clips to calculate the EF.
Accordingly, it eliminates the time-consuming manual process of choosing views.
Bay Labs co-founder and CEO Charles Cadieu said: “At Bay Labs, our hope is that EchoMD AutoEF will assist cardiologists in their decision making and enhance the care they provide to their patients.
“We look forward to continuing to develop unique deep learning technologies that enable expanded access to high-quality echocardiography image acquisition and interpretation, with the goal to improve disease management and patient outcomes through earlier detection and monitoring.”
The artificial intelligence-based EchoMD AutoEF software algorithm is trained on clip selection and EF calculation. The training included analysis of a dataset containing more than 4 million from 9,000 patients.
EchoMD AutoEF software is designed to enable swift integration with any form of DICOM PACS medical imaging environment.
The combination will allow the cardiologists to receive echocardiogram analysis seamlessly to facilitate diagnostic workflow.
Bay Labs expects that the introduction of EchoMD AutoEF will provide better medical services and care to cardiac patients.