FDA clears new AI-powered cardiac imaging solution

"DiA Imaging Analysis, an Israel-based healthcare technology company, has gained U.S. Food and Drug Administration (FDA) clearance for LVivo IQS, a new software solution designed to help users acquire high-quality echocardiography images, regardless of their experience.

LVivo IQS uses artificial intelligence (AI) to provide users with real-time feedback related to image quality. As the imaging exam is being performed, LVivo IQS scans the patient’s left ventricle and tracks the heart’s overall performance; it also rates the quality of the image being acquired, using colors and numerical scoring that guide the user as needed.

The FDA made its decision after reviewing data from a clinical study that compared the software’s quality scores with the opinions of experienced cardiologists who specialize in echocardiography. Overall, 91% of point-of-care ultrasound images acquired by residents who used the solution were found to be clinically useful.

“LVivo IQS is the first of DiA’s nine FDA-approved software solutions that empowers healthcare professionals with real-time feedback to enable the capture of high-quality ultrasound images,” Hila Goldman-Aslan, CEO & founder of DiA Imaging Analysis, said in a prepared statement. “By harnessing the power of AI, our full suite of software solutions helps ultrasound users overcome two major challenges in the field—scanning high-quality images and accurately analyzing them. This holistic approach aligns with our mission of leveraging AI to make ultrasound image capture and analysis processes smarter and more accessible.”..." Lire la suite