Summary: AISAP received FDA 510(k) clearance for its AI-powered AISAP Cardio point-of-care ultrasound software platform, which aids clinicians in diagnosing common cardiac conditions quickly at the bedside.

Key Takeaways:

  • AISAP Cardio software integrates computer-assisted diagnosis for various cardiac conditions, generating reports in minutes.
  • The platform supports a wide range of cardiac measurements, helping clinicians make informed decisions at the point of care.
  • The solution is vendor-agnostic and integrates with existing clinical workflows, EHR/EMR, and PACS technologies.

AISAP, a medical technology company developing AI-powered point-of-care assisted diagnosis (POCAD) solutions for medical ultrasound, announces that the U.S. FDA has granted 510(k) clearance for its AI-powered AISAP Cardio point-of-care ultrasound (POCUS) software platform.

Comprehensive Cardiac Ultrasound Solution

The cloud-based platform combines four computer-assisted diagnosis (CADx) modules of valvular pathologies and eight key measurements into a single, comprehensive cardiac ultrasound software package that automatically generates analyses, interpretations, and reports.

According to AISAP, Cardio empowers 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.

Key Cardiac Parameters Assessed by AISAP Cardio

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, right and left ventricular dimensions, right ventricular fractional area change, atrial areas, ascending aorta diameter, and inferior vena cava diameter.

The platform is designed to generate reliable and validated assessments early in the patient evaluation process and whenever needed during the course of therapy. It is a vendor-agnostic, scalable solution that integrates into the clinical workflow, as well as existing EHR/EMR and PACS technologies. 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. The platform also offers telemedicine, cloud computing, and education tools.

Clinical Validation and Development

“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,” says Adiel Am-Shalom, CEO, AISAP.

Cardio was trained on hundreds of thousands of studies comprising over 24 million echo video clips. AISAP’s novel algorithms on POCUS devices have 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, according to the company.