FDA Clears Viz.ai’s Subdural Plus AI Tool for Brain Hemorrhage Assessment

Viz.ai has received 510(k) clearance from the FDA for its Viz Subdural Plus module, the first AI-powered tool to quantify subdural hemorrhages on non-contrast CT scans. The software automatically labels subdural collections and provides key metrics such as volume, thickness, and midline shift, supporting faster, more accurate clinical decisions.

With chronic subdural hematoma expected to become the most common adult cranial neurosurgical condition in the U.S. by 2030, the tool addresses growing demand for automated, precise evaluation—particularly for procedures like middle meningeal artery (MMA) embolisation.

Part of the Viz.ai One platform, already in use across 1,800 hospitals, the module replaces a traditionally manual process with AI-driven speed and consistency, enhancing critical care and improving patient outcomes.

19-06-2025