Viz.ai gets FDA nod for Viz Subdural Plus

Viz.ai has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Viz Subdural Plus software.

Example of a slice from the segmentation series output. The color overlay gradient in the slice from the segmentation series output corresponds to the Hounsfield Unit (HU) of each corresponding pixel in the non-contrast CT image.Viz Subdural Plus software.Viz.ai

The software quantifies the size of collections such as subdural hemorrhages in the subdural space on noncontrast CT images. It's designed to support clinical decision-making by automatically labeling subdural collections and reporting measurements, including volume, thickness, and midline shift, according to the vendor.

It also supports clinicians in streamlining subdural collection analysis through automation, Viz.ai said. The software is available as part of the Viz.ai One platform.

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