Adjunctive AI Software for Cardiac Ultrasound Gets FDA Nod

The Food and Drug Administration (FDA) has granted 510(k) clearance to LVivo IQS (DiA Imaging Analysis), which facilities heart assessment through an artificial intelligence (AI)-enabled quality scoring system for cardiac ultrasound images.

As clinicians perform ultrasound scanning of the left ventricle of the heart, the LVivo IQS (Image Quality Score) generates colors and numerical scoring to provide real-time assessment of image quality, according to DiA Imaging Analysis.

In a clinical study assessing the AI-powered image scoring system, DiA Imaging Analysis found that 91 percent of point-of-care cardiac ultrasound images obtained by residents using the LVivo IQS software were deemed to be clinically interpretable images by cardiologists.

Lior Fuchs, M.D., the principal investigator of the study, said LVivo IQS is a significant advance in the cardiac ultrasound arena.

“For precise heart diagnosis and treatment, high-quality cardiac ultrasound imaging is necessary in both point-of-care and other settings,” noted Dr. Fuchs, a senior intensive care physician affiliated with the Soroka Medical Center in Israel. “LVivo IQS AI software will assist us in obtaining faster and clearer images to aid our real-time clinical decision-making process.”

(Editor’s note: For related content, see “Clarius Mobile Health Gets FDA Nod for AI Ultrasound Musculoskeletal Imaging Model” and “Pie Medical Imaging Launches AI-Powered Echocardiography Platform.”)