The FDA has authorised AISAP's AI-powered point-of-care ultrasound (POCUS) software platform to rapidly diagnose structural heart disease and heart failure.

The AISAP CARDIO tool enables clinicians who have basic scanning skills to diagnose up to 90% of common cardiac structural and functional parameters at the bedside in minutes.

The cloud-based platform integrates four computer-assisted diagnosis modules for valvular pathologies with eight key measurements into a single software package to automatically generate analyses, interpretations and reports. 

The device is designed to assess and evaluate several cardiac structural functional parameters, including the presence of valvular pathology 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 vendor-agnostic, scalable solution connects with clinical workflows, as well as existing EHR/EMR and PACS systems, while also offering telemedicine, cloud computing and education tools.

Extensively trained 

The CARDIO device was trained on hundreds of thousands of studies consisting of over 24 million echo video clips, while the company's POCUS algorithms have been validated in several clinical trials.

Studies have shown that AISAP CARDIO enables non-cardiologist physicians to interpret point-of-care echocardiograms as effectively as expert cardiologists at Mass General Brigham’s (MGB) echocardiography lab.

Testing revealed that measurements taken by the device were as close to, or often closer than, the mean of three MGB cardiologists versus each individual cardiologist, while standalone performance for significant major valve disease pathology achieved 93% sensitivity and 93% specificity.

Meanwhile, prospective data have also shown that CARDIO improved clinician performance, with care pathway changes seen in one third of scanned patients. 

In May, AISAP secured $13 million in seed funding. The company's platform will be commercially available on September 1.