receives FDA 510(k) clearance for cerebral aneurysm detection algorithm


viz has received US Food and Drug Administration (FDA) 510(k) clearance for Viz ANEURYSM—a new algorithm that uses artificial intelligence (AI) to detect suspected cerebral aneurysms. According to a company press release, this is intended to help hospital systems ensure that, once detected, patients are captured and the aneurysm workflow across an entire health system is standardised, allowing patients to receive the appropriate follow-up care and creating significant financial benefits for hospital systems and payers.

Viz ANEURYSM will serve as a first of its kind population health tool to facilitate population screening and enhanced care management, the release adds.

A study at the University of Toronto (Toronto, Canada) tested the accuracy of Viz ANEURYSM using 528 computed tomography angiographies (CTAs) with 674 aneurysms broadly distributed across the cerebral vascular territories, encompassing anterior and posterior circulation. Data analysis demonstrated 94% accuracy for the algorithm.

“[Aneurysms] can be often missed because they require a very methodical diagnostic approach,” said Vitor Mendes Pereira (University of Toronto, Toronto, Canada). “The 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.”

The Viz ANEURYSM module is additive to the Viz Intelligent Care Coordination platform, which is clinically validated and reimbursed by Medicare and proven to save time, and improve patient outcomes and access to care, the release also notes.


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