AISAP’s CARDIO Ultrasound Diagnostic Assessment Software Receives FDA Clearance

AISAP, a medical technology company developing AI-powered Point-of-Care Assisted Diagnosis (POCAD) solutions to transform medical ultrasound, has received 510(k) clearance by the FDA for its first-of-a-kind, AI-powered AISAP CARDIO point-of-care ultrasound (POCUS) software platform. 
 
AISAP CARDIO is a cloud-based platform that combines four computer-assisted diagnosis (CADx) modules of valvular pathologies and eight key measurements into a comprehensive, cardiac ultrasound software package that generates analyses, interpretations, and reports. 
 
CARDIO empowers clinicians with basic scanning skills to accurately diagnose up to 90% of the most common cardiac structural and functional parameters at the patient’s bedside within minutes.
 
The platform is designed to generate reliable and validated assessments early in the patient evaluation process and whenever needed during therapy. It is a vendor-agnostic, scalable solution that seamlessly integrates into the clinical workflow, as well as existing EHR/EMR and PACS systems. 
 
The software generates accurate reports in minutes using inexpensive devices, enabling emergency medicine, critical care, internal medicine, hospitalists, and primary care physicians to make informed care decisions at the bedside. 
 
AISAP CARDIO is indicated to provide diagnostic assessment and measurements of several key cardiac structural-functional parameters, including presence of valvular pathology (regurgitations of the mitral, tricuspid, aortic valves, and aortic stenosis), and measurements of left ventricle ejection fraction (LVEF), right and left ventricular dimensions, right ventricular fractional area change (RV FAC), atrial areas, ascending aorta diameter, and inferior vena cava (IVC) diameter.
 
“AISAP CARDIO has the potential to be a game-changer in the world of point-of-care ultrasound,” said Smadar Kort, MD, system director of Non-Invasive Cardiac Imaging, Stony Brook Medicine, and past governor of the American College of Cardiology. “We know that structural heart disease and heart failure are the leading causes of hospitalization and morbidity in the U.S. 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.”
 
“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,” said Adiel Am-Shalom, CEO, AISAP.
 
“This milestone makes AISAP the first company in the world to secure FDA clearance in the CADx pathway for the comprehensive diagnosis of structural heart diseases using POCUS. It marks a big step in our goal of delivering point-of-care assisted diagnosis, or POCAD, with unparalleled scalability and accessibility – from the largest academic centers to the most remote rural locations,” added Ehud Raanani, MD, co-founder, AISAP, and director, Leviev Cardiovascular and Thoracic Center, Sheba Medical Center.
 
Recent data have shown that the use of CARDIO has generated improvement in clinician performance, with care pathway changes in one-third of scanned patients.¹ The platform also offers telemedicine, cloud computing, and education tools.
 
The accuracy and impact of the novel CARDIO algorithms on POCUS cases were shown in standalone model performance and clinical reader performance studies led by Dr. James Hillis, MBBS, DPhil, director of Clinical Operations at Mass General Brigham AI. 
 
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 3 MGB cardiologists than each cardiologist. Standalone performance for significant major valve disease pathology (aortic stenosis and regurgitation and mitral and tricuspid regurgitation) had a 93 percent sensitivity and 93 percent specificity.²
 
CARDIO was trained on hundreds of thousands of studies comprising over 24 million echo video clips. AISAP’s novel algorithms on POCUS devices has been validated in multi-national, multi-site, randomized, multi-reader, multi-case clinical trials at Mass General Brigham, Thomas Jefferson University Hospital, Mayo Clinic, Inova Fairfax Medical Campus, Crozer-Chester Medical Center and Stony Brook University Hospital.
 
CARDIO will be available for commercial use on September 1. 

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