Viz.ai’s AAA Algorithm Receives FDA 510(k) Clearance

March 21, 2023—Viz.ai announced it has received FDA clearance for its algorithm intended to detect suspected abdominal aortic aneurysms (AAAs).

According to the company, Viz AAA uses artificial intelligence (AI) to automatically search for the presence of a AAA from CT angiography from any scanner in a hospital network. The new AI algorithm and clinical workflow solution will be a part of the Viz Aortic Module, an AI solution designed to accelerate treatment decisions for all aortic pathologies.

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, stated the company.

“There are an estimated 1.1 million Americans living with an AAA,” commented Philip Batista, MD, in the company’s press release. “A 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.”

Dr. Batista, who is Associate Program Director, Vascular and Endovascular Surgery Residency, Cooper University Health Care in Camden, New Jersey, continued, “This algorithm is a powerful new tool for health care professionals to more readily identify and capture individuals with AAA and, importantly, automatically refer those at imminent risk for rupture.”

Patrick Muck, MD, a vascular surgeon at TriHealth in Cincinnati, Ohio, stated in the Viz.ai press release, “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. 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.”