AISAP, a company that develops AI-powered point-of-care assisted diagnosis solutions, has announced that the FDA granted 510(k) clearance for its CARDIO point-of-care ultrasound (POCUS) software platform.

Clinicians with basic scanning skills can use this tool to accurately diagnose up to 90% of the most common cardiac structural and functional parameters at the patient's bedside.

"More and more medical organizations and clinicians from a variety of specialties are adopting the POCUS devices as part of their medical clinic," Adiel Am-Shalom, CEO, AISAP, told HCB News. "With this adoption, two significant needs arise: first, improving the capabilities of performing the scan and acquiring high-quality images; second, interpreting the images in order to reach a clinical diagnosis and therapeutic decisions."

He added that CARDIO can help clinicians meet those needs because it standardizes the POCUS test's workflow. It generates a report in minutes and also can integrate with any POCUS system and electronic health system.

It was trained using hundreds of thousands of studies that encompassed more than 24 million echocardiogram video clips. As a result, CARDIO can assess the presence of valvular pathology such as regurgitations of the mitral, tricuspid, and aortic valves, and aortic stenosis.

It can also measure left ventricle ejection fractions, right and left ventricular dimensions, right ventricular fractional area change, atrial areas, ascending aorta diameter, and inferior vena cava diameter.

Am-Shalom explained that CARDIO can be used as part of a physical examination, at the triage in the emergency room or admission in the hospital ward, and also to monitor the heart's function before and after a procedure.

"The physician performs the scan, the images are analyzed in our software, and finally a short report is received in the patient's medical file, which is billable," he added.

The platform's algorithms were validated in clinical trials that took place at six health systems including Mass General Brigham (MGB) and Mayo Clinic. The MCB studies have shown that CARDIO allows non-cardiologist physicians to interpret point-of-care echocardiograms as well as expert cardiologists in the MGB echocardiography lab.

With yesterday's announcement, AISAP is now the first company globally to obtain FDA clearance in the CADx pathway for the comprehensive diagnosis of structural heart diseases using POCUS. According to the company, CARDIO will be commercially available starting September 1.

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