SAN FRANCISCO– Viz.ai has received FDA 510(k) clearance for its Viz Subdural Plus module, making it the first and only AI-powered solution approved for automatically measuring subdural hemorrhages on non-contrast CT scans. The breakthrough tool enables precise labeling, visualization, and quantification of subdural collections, helping physicians make faster and more informed treatment decisions.
Designed to operate within the Viz.ai One platform, Viz Subdural Plus streamlines a process that has traditionally required manual analysis by clinicians. The AI-powered module provides volumetric data, maximum thickness, and midline shift measurements directly from NCCT imaging, supporting faster diagnosis and treatment planning—particularly for patients with chronic subdural hematoma (SDH).
“Viz Subdural Plus introduces a new level of precision in diagnosing and monitoring subdural hemorrhage,” said Dr. David J. Altschul, Division Chief of Cerebrovascular Neurosurgery at Montefiore Health System. “Having automated volume and max thickness measurements at our fingertips allows us to make faster, more informed treatment decisions—especially critical in managing elderly patients or those on anticoagulants.”
The clearance comes at a time of growing clinical need. Chronic subdural hematomas are expected to become the most common cranial neurosurgical condition in adults, with projections estimating up to 60,000 new cases per year in the U.S. by 2030. The rise is linked to an aging population and increased use of blood-thinning medications. Quantifying the extent of subdural collections is vital for assessing severity, tracking changes over time, and determining treatment strategies, such as middle meningeal artery (MMA) embolization—a minimally invasive procedure increasingly used to prevent recurrence.
With Viz Subdural Plus, clinicians can eliminate the time-consuming and often variable manual measurement process. The tool fits into Viz.ai’s broader Viz Neuro Suite, which is currently used in more than 1,800 hospitals and health systems nationwide.
“As the incidence of chronic subdural hematomas grows, so does the need for intelligent tools that can standardize and accelerate clinical decision-making,” said Justin Ryea, Senior Director of Product Management at Viz.ai. “This latest addition to the Viz Neuro Suite reinforces our commitment to addressing high-impact conditions and improving outcomes at scale.”
By combining advanced AI with real-time workflow integration, Viz Subdural Plus aims to reduce variability in care and enhance the precision of neurological treatment planning, particularly in urgent or complex cases.
