FDA hands DiA Imaging another AI clearance in cardiac ultrasound

The FDA has cleared an artificial intelligence program designed to provide a helping hand to clinicians conducting cardiac ultrasound exams developed by DiA Imaging Analysis. 

The Israel-based company’s LVivo IQS aims to be a vendor-neutral AI software package that provides real-time feedback to the user while they perform a scan.

By changing colors and displaying a numerical score to rate the overall quality of an image of the left ventricle, DiA hopes to assist technicians in capturing clear and accurate scans that can be used to diagnose a range of potentially hidden heart conditions.

The program is DiA’s ninth to receive an FDA green light though its first to offer real-time feedback. Other offerings have provided automated heart ultrasound measurements such as for cardiac ejection fraction and muscle strain as well as software for detecting the signs of a heart attack or a blocked bladder.

According to the company, LVivo IQS demonstrated in a clinical study that its ratings of higher-quality ultrasound images collected by medical residents at the point of care were also found to be largely interpretable by a cardiologist specializing in echocardiograms.

The company previously inked a deal with GE Healthcare to pair its ejection fraction program, which measures the changing volume of the heart’s chambers as it pumps blood to the body, with the medtech’s Vscan hand-held ultrasound scanners. More recently, it has teamed up with the likes of Intel and ScImage to expand its reach in AI and deep learning. 

Last year, DiA said it would work with Intel on speeding up the processing time of its echocardiogram workflow algorithms, such as LVivo Seamless, which helps select the best heart images for review. Meanwhile, the company also tapped the California-based ScImage to place those programs in the cloud.

AI-powered heart ultrasounds have been fertile ground for FDA clearances in the past few years. One of the agency’s earliest clearances for an AI guidance program went to Caption Health in early 2020. Since then the FDA has greenlit software from GE Healthcare and Ultromics, among others.