The US Food and Drug Administration (FDA) has issued 510(k) clearance for AISAP’s AI-powered CARDIO point-of-care ultrasound (POCUS) diagnostic software.

The cloud-based platform is designed to assist clinicians with basic scanning skills in key cardiac structural functional parameters quickly and accurately at the bedside.

These parameters include valvular pathology presence, and measurements of left ventricle ejection fraction (LVEF), right and left ventricular dimensions, atrial areas, right ventricular fractional area change (RV FAC), ascending aorta diameter, and inferior vena cava (IVC) diameter.

Commercial availability of Cardio is set for 1 September 2024.

AISAP CEO Adiel Am-Shalom said: “AISAP CARDIO was developed by top-notch technologists and cardiologists to close critical gaps in patient care. Our ‘anywhere, anytime AI’ approach is aimed at transforming healthcare by bringing cutting-edge diagnostic tools to the point of care.”

Cardio combines computer-assisted diagnosis modules and key measurements to generate analyses, interpretations, and reports.

It integrates seamlessly into existing clinical workflows and systems, aiming to provide reliable assessments early inpatient evaluation and throughout therapy.

Cardio is a vendor-agnostic, scalable solution and offers telemedicine and education tools, generating reports using inexpensive devices. The software was trained on a vast dataset and validated through extensive clinical trials at leading medical institutions.

The software demonstrated high sensitivity and specificity for major valve disease pathology in clinical studies.

Stony Brook Medicine Non Invasive Cardiac Imaging system director Smadar Kort said: “AISAP CARDIO has the potential to be a game-changer in the world of point-of-care ultrasound.”