Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance, is an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence to help the user capture images of a patient’s heart that are of acceptable diagnostic quality.
The Caption Guidance software is indicated for use in ultrasound examination of the heart, known as two-dimensional transthoracic echocardiography (2D-TTE), for adult patients, specifically in the acquisition of standard views of the heart from different angles. These views are typically used in the diagnosis of various cardiac conditions.
“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and treatment of heart disease,” said Robert Ochs, Ph.D., deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others, to use this tool. This is especially important because it demonstrates the potential for artificial intelligence and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients.”