AISAP receives FDA approval for cardiac ultrasound software platform
AISAP receives FDA approval for cardiac ultrasound software platform
The cloud-based platform combines AI diagnostics and detailed measurements for rapid and accurate diagnosis of structural heart disease.
AISAP, which develops AI-powered Point-of-Care Assisted Diagnosis (POCAD) solutions, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its AI-powered AISAP CARDIO point-of-care ultrasound (POCUS) software platform. 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.
AISAP, which developed in cooperation with Sheba Medical Center's ARC Innovation Center, raised $13 million in Seed funding in May of this year. The round was led by Harel Insurance Investments & Financial Services Ltd., and Shoni Top Ventures, L.P.
The company was founded by Adiel Am-Shalom, who managed R&D and Cyber teams in the Israel Defense Force’s 8200 intelligence unit and the founder of IDL; Ehud Raanani, Director of the Leviev Cardiovascular and Thoracic Center at Israel’s Sheba Medical Center; Robert Klempfner, Director of the Israeli Center for Cardiovascular Research; and Ehud Schwammenthal, an expert in echocardiography and the founder of Ventor Technologies and Magenta Medical.
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 (LVEF), right and left ventricular dimensions, right ventricular fractional area change (RV FAC), atrial areas, ascending aorta diameter, and inferior vena cava (IVC) 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 seamlessly integrates into the clinical workflow, as well as existing EHR/EMR and PACS systems.
“This milestone makes AISAP the first company in the world to secure FDA clearance in the CADx pathway for the comprehensive diagnosis of structural heart diseases using POCUS,” said Adiel Am-Shalom, CEO of AISAP, which employs around 20 people.
CARDIO was trained on hundreds of thousands of studies comprising over 24 million echo video clips. AISAP’s novel algorithms on POCUS devices has 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.
