Aisap’s Cardio Diagnostic Assessment Software Platform Receives FDA Clearance

August 22, 2024—Aisap announced FDA 510(k) clearance for Cardio, its artificial intelligence- (AI-) powered point-of-care ultrasound (POCUS) software platform. Cardio will be commercially available on September 1.

According to the company, the cloud-based Cardio platform combines four computer-assisted diagnosis modules of valvular pathologies and eight key measurements into a single, comprehensive, cardiac ultrasound software package that automatically generates analyses, interpretations, and reports. Cardio is intended to provide clinicians with basic scanning skills to accurately diagnose up to 90% of the most common cardiac structural and functional parameters right at the bedside within minutes.

The company advised that Aisap Cardio is indicated to provide diagnostic assessment and measurements of several key cardiac structural functional parameters including the following: the presence of valvular pathology (regurgitations of the mitral, tricuspid, aortic valves, and aortic stenosis), and measurements of left ventricle ejection fraction, right and left ventricular dimensions, right ventricular fractional area change, atrial areas, ascending aorta diameter, and inferior vena cava diameter.

“Aisap Cardio has the potential to be a game-changer in the world of point-of-care ultrasound,” commented Smadar Kort, MD, in the company’s press release. “We know that structural heart disease and heart failure are the leading causes of hospitalization and morbidity in the United States. Enabling a wide variety of qualified physicians to quickly and accurately diagnose these conditions at the bedside could lead to earlier detection and treatment, and better patient outcomes, as well as greater efficiencies and cost savings to health systems, while ultimately saving countless lives.”

Dr. Kort is system director of Non-Invasive Cardiac Imaging, Stony Brook Medicine in Stony Brook, New York, and a past governor of the American College of Cardiology, noted the company.

The company advised that the accuracy and impact of the Cardio algorithms on POCUS cases were shown in standalone model performance and clinical reader performance studies led by James Hillis, MBBS, DPhil, director of Clinical Operations at Mass General Brigham (MGB) AI in Boston, Massachusetts.

As summarized by the company, data from the studies demonstrated that Aisap Cardio enables non-cardiologist physicians to interpret point-of-care echocardiograms just as well as expert cardiologists of the MGB echocardiography lab.

That testing demonstrated that measures performed by the Aisap Cardio device were as close or even frequently closer to the mean of three MGB cardiologists than each individual cardiologist. Standalone performance for significant major valve disease pathology (aortic stenosis and regurgitation and mitral and tricuspid regurgitation) had a 93% sensitivity and 93% specificity, stated Aisap.