FDA Clears CT-Based AI Software for Subdural Collections

Viz.ai Receives FDA Clearance for Subdural Measurements

New AI algorithm enables precise and reliable labeling, visualization and quantification of subdural hemorrhage to make accurate and timely treatment decisions.

FDA Clears CT-Based AI Software for Subdural Collections

The AI-powered Viz Subdural Plus reportedly provides automated measurements and labeling of subdural collections, including subdural hemorrhages (SDHs), based on non-contrast CT scans.

Viz.ai’s Viz Subdural Plus Cleared for Quantifying Collections of Subdural Hemorrhages - Endovascular Today

June 12, 2025—Viz.ai announced it has received FDA 510(k) clearance for Viz Subdural Plus, a comprehensive solution for quantifying the size of collections like subdural hemorrhages (SDH) in the subdural space on noncontrast CT images. Viz.ai stated that the Viz Subdural Plus module is designed to support clinical decision-making by automatically labeling subdural collections and reporting measurements, including volume, thickness, and midline s…