Viv.ai Receives FDA 510(k) Clearance for Abdominal Aortic Aneurysm Algorithm

Viz.ai, a company focused on AI-powered disease detection and intelligent care coordination, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to detect suspected abdominal aortic aneurysm (AAA). Viz AAA is the first FDA-cleared AI-powered solution for the detection and triage of suspected AAA.

Viz AAA uses artificial intelligence to automatically search for the presence of an abdominal aortic aneurysm from any computed tomography angiography (CTA) scan of the chest from any scanner in a hospital network. The new artificial intelligence (AI) algorithm and clinical workflow solution will be a part of the VizTM AORTIC Module, an AI solution designed to accelerate treatment decisions for all aortic pathology.

An abdominal aortic aneurysm is a bulge in the abdominal aorta, the main artery that carries blood from the heart to the rest of the body. If left undetected and untreated, AAA can lead to a rupture, which is often fatal. According to the Centers for Disease Control and Prevention, AAA is responsible for more than 10,000 deaths each year in the United States alone. The software can be integrated into existing hospital workflows, allowing physicians to quickly and easily identify patients who may have a suspected AAA and take appropriate measures to prevent a rupture.

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