FDA clears Viz.ai's cerebral aneurysm software

By AuntMinnie.com staff writers

February 24, 2022 -- Viz.ai has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AI algorithm that detects aneurysms on CT angiography (CTA) scans.

Viz Aneurysm is an addition to the company's Viz Intelligent Care Coordination Platform, which offers a number of algorithms for clinical application in ischemic and hemorrhagic stroke, pulmonary embolism, and aortic disease. The platform is covered by Medicare and is installed in more than 1,000 hospitals, Viz.ai said.

Viz Aneurysm was tested in a study published in Stroke last year that found the algorithm was able to detect and measure ruptured and unruptured aneurysms with 94% accuracy in 528 consecutive CTA scans with 674 aneurysms broadly distributed across the cerebral vascular territories.

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