FDA Clears AISAP?s CARDIO AI Ultrasound Diagnostic Software for Cardiac Point-of-Care Use
23 August 2024
AISAP has achieved FDA 510(k) clearance for its innovative AISAP CARDIO point-of-care ultrasound (POCUS) software platform.
This advanced, cloud-based system integrates four computer-assisted diagnosis (CADx) modules and eight essential cardiac measurements into a unified solution.
AISAP CARDIO automatically generates analyses, interpretations, and reports, enabling clinicians with basic ultrasound skills to diagnose up to 90% of common cardiac conditions quickly and accurately at the bedside.
The platform is designed to assess various cardiac parameters, including valvular pathologies and measurements of heart dimensions and function. It integrates seamlessly with existing EHR/EMR and PACS systems, providing reliable assessments throughout the patient’s care.
Studies have demonstrated that AISAP CARDIO can improve clinician performance and influence care pathways in a significant number of cases.
Developed using advanced algorithms trained on extensive datasets, AISAP CARDIO has been validated in trials conducted at prominent institutions such as Mass General Brigham and Mayo Clinic.
These studies confirmed that the platform enables non-cardiologist physicians to interpret echocardiograms with accuracy comparable to expert cardiologists, achieving high sensitivity and specificity for detecting major valve diseases.
The AI-driven approach of AISAP CARDIO aims to make sophisticated diagnostic tools widely accessible at the point of care, from large academic centers to remote locations.
Source: businesswire.com