Israel-based AISAP has received 510(k) clearance from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-powered AISAP Cardio point-of-care ultrasound (POCUS) software platform.
AISAP is a medical technology firm specialising in the development of AI-driven point-of-care assisted diagnosis (POCAD) solutions.
AISAP Cardio is a cloud-based platform that integrates four computer-assisted diagnosis (CADx) modules for valvular pathologies and eight essential measurements into one all-encompassing cardiac ultrasound tool.
It automatically produces analyses, interpretations, and reports, enabling clinicians with basic scanning skills to diagnose up to 90% of the most common cardiac structural and functional parameters at the bedside.
AISAP Cardio is designed to provide diagnostic assessments and measurements of several cardiac parameters.
This includes evaluating valvular pathologies and measuring left ventricular ejection fraction (LVEF) and right and left ventricular dimensions.
It also helps assess right ventricular fractional area change (RV FAC), atrial areas, ascending aorta diameter, and inferior vena cava (IVC) diameter.
The platform aims to deliver reliable and validated assessments early in the patient evaluation process and as needed throughout therapy.
According to AISAP, the solution is a vendor-agnostic, scalable solution that integrates into clinical workflows, as well as existing EHR/EMR and PACS systems.
Cardio empowers physicians to make informed decisions by generating reports within minutes using cost-effective devices.
Prospective data have indicated that the ultrasound diagnostic assessment software has improved clinician performance, leading to changes in care pathways for one-third of scanned patients.
Additionally, the platform supports telemedicine, cloud computing, and educational tools.
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 was trained using several studies and over 24 million echo video clips.
Studies showed that AISAP Cardio allows non-cardiologist physicians to interpret point-of-care echocardiograms like cardiologists.
The performance of Cardio’s measurements matched or exceeded the average of three cardiologists from the MGB echocardiography lab.
The software Cardio demonstrated 93% sensitivity and 93% specificity for detecting major valve diseases like aortic stenosis and regurgitation, as well as mitral and tricuspid regurgitation.
