AISAP CARDIO: FDA-Cleared AI-Powered Ultrasound Diagnostic Tool

AISAP has announced that its AI-powered AISAP CARDIO point-of-care ultrasound (POCUS) software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This cloud-based platform integrates four computer-assisted diagnosis (CADx) modules and eight key cardiac measurements into a single comprehensive ultrasound software tool. It allows clinicians, even those with basic scanning skills, to accurately diagnose up to 90% of the most common cardiac conditions, such as valvular pathologies, within minutes at the bedside. This is particularly important in the context of structural heart disease and heart failure, which are leading causes of hospitalization in the U.S. By enabling physicians to make rapid diagnoses, AISAP CARDIO could improve patient outcomes through early detection and treatment while also increasing efficiency in healthcare systems. The platform is designed to evaluate a range of cardiac parameters, including left ventricle ejection fraction, right and left ventricular dimensions, and aortic measurements. The software produces reliable diagnostic reports in minutes, providing physicians with essential data to inform care decisions. Its vendor-agnostic design integrates seamlessly into existing clinical workflows and electronic health records. Studies have shown that using AISAP CARDIO can lead to improved clinician performance, with care pathways changing in one-third of cases. Trained on over 24 million echo video clips, AISAP CARDIO has been validated through multi-site, clinical trials, demonstrating accuracy comparable to expert cardiologists. This groundbreaking FDA clearance marks AISAP’s success in achieving a comprehensive diagnosis of structural heart diseases using POCUS and highlights the potential for broader access to diagnostic tools in both urban and rural healthcare settings.