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FDA Clears Israel’s AISAP’s AI-Powered Cardiac Ultrasound Software for Point-of-Care Diagnosis

The cloud-based CARDIO software integrates four computer-assisted diagnosis (CADx) modules for valvular pathologies and eight key measurements into a single, comprehensive package.

AISAP

AISAP’s CARDIO AI-powered Point-of-Care Ultrasound Diagnostic Assessment Software

AISAP, a medical technology company specializing in AI-powered Point-of-Care Assisted Diagnosis (POCAD) solutions for medical ultrasound, has secured 510(k) clearance from the FDA for its innovative AISAP CARDIO software platform. This groundbreaking platform, the first of its kind, leverages AI to assist clinicians in cardiac ultrasound (POCUS) diagnosis.

The cloud-based CARDIO software integrates four computer-assisted diagnosis (CADx) modules for valvular pathologies and eight key measurements into a single, comprehensive package. It automatically generates analyses, interpretations, and reports, empowering clinicians with basic scanning skills to accurately diagnose up to 90% of common cardiac structural and functional parameters at the bedside within minutes.

Located in Tel Aviv and founded by Chief Medical Officer Prof. Robert Klempfner and CEO Adiel Am-Shalom, AISAP Ltd is the brainchild of a multidisciplinary team of AI & Deep learning top-notch experts and leading physicians with deep clinical and research expertise. The AISAP platform is a high-performance AI solution for real-time diagnosis, interpretation, storing, and reporting of ultrasound studies at the point of care.

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Inbal Zafir-Lavie has vast experience in leading IND enabling studies, developing CLIA compliant lab tests, performing due diligence for new drugs and technologies, supporting FDA IND and 510(k) submissions. She is an expert in the fields of gene therapy, molecular immunology, and antibody engineering and graduated with a PhD (direct course) cum laude, from Technion- Israel institute of technology.

“AISAP CARDIO was developed by top-notch technologists and cardiologists to close critical gaps in patient care. Our ‘anywhere, anytime AI’ approach is aimed at transforming healthcare by bringing cutting-edge diagnostic tools to the point of care,” said Adiel Am-Shalom, CEO, AISAP.

AISAP boasts a user-friendly SAAS platform with AI-powered ultrasound diagnosis. From scan to report within minutes as well as real-time scanning assistance for best image acquisition. Thus, says the firm, can improve performance by data driven analytics and insights to the operator and it also “seamlessly integrates” with any point of care ultrasound device (POCUS) and with electronic health systems protocols and API’s.

Ultrasound is a medical imaging technique that uses high-frequency sound waves to create images of the inside of the body. It is a safe and painless procedure that can be used to diagnose a wide range of medical conditions.

An ultrasound machine uses a transducer to emit sound waves into the body. The sound waves are reflected back to the transducer by different tissues in the body, depending on their density. The transducer then converts these reflected sound waves into electrical signals that are displayed on a monitor as an image.

Ultrasound images can be used to see the size, shape, and structure of organs and tissues in the body. They can also be used to see blood flow and to measure the thickness of tissues.

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