Viz.ai Awarded FDA 510(k) Clearance for Its Aneurysm Detector

March 1, 2022

The FDA has granted 510(k) marketing clearance to artificial intelligence (AI) medical device software company Viz.ai’s cerebral aneurysm detecting software.

The Viz ANEURYSM algorithm uses an algorithm to detect suspected cerebral aneurysms from computed tomography angiography (CTA) images. In a study at the University of Toronto, the software demonstrated 94 percent accuracy in detecting aneurysms from 528 CTAs.

The aneurism detection software is an add-on to the Viz intelligent care coordination platform, which is reimbursable by Medicare, the company said.

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