FDA Clears Viz.ai\'s AI Algorithm for Abdominal Aortic Aneurysm

FDA Clears Viz.ai\'s AI Algorithm for Abdominal Aortic Aneurysm sbrusco@rodmanmedia.com (Sam Brusco)

Viz.ai has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its algorithm to spot suspected abdominal aortic aneurysm (AAA). According to the company, Viz AAA is the first FDA-cleared, AI-powered solution to detect and triage suspected AAA.

“There [are] an estimated 1.1 million Americans living with an AAA. Majority of these patients are asymptomatic and many are unaware of their disease until a rupture occurs. This is a catastrophic medical emergency, resulting in over 10,000 deaths each year,” Philip Batista, MD, Associate Program Director, Vascular and Endovascular Surgery Residency, Cooper, told the press. “This algorithm is a powerful new tool for healthcare professionals to more readily identify and capture individuals with AAA and, importantly, automatically refer those at imminent risk for rupture.

“I look forward to the new aortic platform here at TriHealth, as its implementation will allow for enhanced identification, triage and team member communication, resulting in the best possible care for our aortic patients,” added TriHealth Vascular Surgeon Dr. Patrick Muck. “We’ve been using the Viz software for the detection of suspected pulmonary embolism over the last several months and have seen improvements in patient care across our institution.”

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

An abdominal aortic aneurysm is a bulge in the abdominal aorta. If left undetected and untreated, AAA can lead to an often fatal rupture.

The software can be integrated into existing hospital workflows so physicians can quickly identify patients with a suspected AAA and take measures to prevent a rupture.

“AAA is an important and actionable incidental finding that is too-often missed,” said Jayme Strauss, chief clinical officer at Viz.ai. “The vision behind Viz AAA is to automatically catch and follow abdominal aortic disease, no matter the patient’s location. We believe that this product will enable care teams to prevent catastrophic aortic emergencies, such as aortic rupture, by increasing the surveillance of these patients.”