Artificial intelligence (AI) software developer Bay Labs has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its EchoMD AutoEF automated echocardiography analysis software.
The clearance covers automated clip selection and the calculation of left ventricular ejection fraction (EF), a widely used metric of cardiac function, according to the vendor. EchoMD AutoEF automatically reviews all relevant digital video clips of cardiac cycles from a patient's echocardiography study and then selects the best clips to calculate EF after assessing their image quality, Bay Labs said.
The software's deep-learning algorithms were trained on a curated dataset of more than 4 million images from 9,000 patients. The software can be integrated into any DICOM PACS medical imaging environment, according to the firm.
