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.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the artificial intelligence (AI)-enabled software Viz Subdural Plus, which assesses non-contrast computed tomography (NCCT) scans to offer automated quantification of subdural hemorrhages and other subdural collections.
Viz Subdural Plus provides automated measurements of volume, thickness and midline shifts as well as labeling of subdural collections, according to Viz.ai, the manufacturer of the software.
The newly FDA-cleared Viz Subdural Plus software utilizes AI to provide automated labeling and measurements of volume, thickness and midline shifts for subdural collections, including subdural hemorrhages, based on non-contrast head CTs. (Image courtesy of Viz.ai .)
Emphasizing projections of up to 60,000 cases of chronic subdural hematoma (cSDH) being diagnosed each year in the United States by 2030, Viz.ai maintained that Viz Subdural Plus can enable more timely evaluations, monitoring of progression and treatment decisions including potential use of middle meningeal artery embolization (MMA) embolization.
“Viz Subdural Plus introduces a new level of precision in diagnosing and monitoring subdural hemorrhage,” noted David J. Altschul, M.D., the division chief of cerebrovascular neurosurgery at Montefiore Health System in New York. “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. As we increasingly turn to minimally invasive options like MMA embolization to reduce recurrence, tools like Viz Subdural Plus are essential to guiding timely and effective treatment.”
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