Viz.ai’s Cerebral Aneurysm Detection Module Receives FDA Clearance

February 24, 2022—Viz.ai announced it has received FDA 510(k) clearance for Viz Aneurysm, a new algorithm that uses artificial intelligence (AI) to detect suspected cerebral aneurysms.

The company stated that Viz Aneurysm is intended to facilitate population screening and enhance care management by enabling hospital systems to ensure that after aneurysms are detected, patients are captured and the treatment workflow across an entire health system is standardized.

The Viz Aneurysm module is part of the Viz Intelligent Care Coordination Platform, the company’s neurovascular and vascular AI platform for coordinating care across a broad list of clinical applications, including ischemic and hemorrhagic stroke, pulmonary embolism, and aortic disease.

According to the company, a study at the University of Toronto in Toronto, Canada, tested the accuracy of Viz Aneurysm using 528 CTAs with 674 aneurysms broadly distributed across the cerebral vascular territories, encompassing anterior and posterior circulation. Data analysis demonstrated 94% accuracy for the algorithm. The findings by Vitor Mendes Pereira, MD, et al were presented at the International Stroke Conference 2020 Oral Abstracts session and published in the conference supplement of Stroke (2020;51:A141).

Dr. Mendes Pereira, who is Director of Endovascular Research and Innovation at the University of Toronto, commented in the company’s press release, “[Aneurysms] can be often missed because they require a very methodical diagnostic approach. The Viz.ai aneurysm algorithm was able to detect cerebral aneurysms in consecutive CTAs. The model has demonstrated that a deep learning AI algorithm can achieve clinically useful levels of accuracy for clinical decision support and will help us to improve how we help aneurysm patients.”