First-of-its-kind software aims to improve treatment decisions for patients with chronic subdural hematomas

Viz.ai has received FDA 510(k) clearance for a new software module designed to support the diagnosis and management of subdural hemorrhage (SDH), a condition expected to become the most common cranial neurosurgical issue in adults by 2030.

The newly cleared tool, Viz Subdural Plus, is the first AI-powered solution cleared in the US to quantify the size of subdural collections — such as chronic subdural hematomas — using non-contrast CT (NCCT) scans. According to the company, the software automatically labels subdural collections and reports key measurements, including volume, maximum thickness, and midline shift, to help clinicians make more informed decisions around treatment.

“Viz Subdural Plus introduces a new level of precision in diagnosing and monitoring subdural hemorrhage,” said Dr David Altschul, division chief of cerebrovascular neurosurgery at Montefiore Health System.

“Having automated volume and thickness measurements at our fingertips allows us to make faster, more informed treatment decisions—especially critical in managing elderly patients or those on anticoagulants.”

Chronic SDH is increasingly common among older adults and those taking antiplatelet or anticoagulant medications. With around 60,000 new cases projected annually in the US by the end of the decade, timely diagnosis and treatment are essential. In some cases, clinicians are turning to less invasive approaches such as middle meningeal artery (MMA) embolization to reduce recurrence risk—decisions that depend on accurate volume assessments.

Viz Subdural Plus is designed to streamline a previously manual and time-consuming process by automating subdural collection measurement. It is offered as part of the Viz.ai One platform, which is currently in use across more than 1,800 hospitals and health systems in the US.

“With an aging population, the incidence of chronic subdural hematomas is rising, and so is the need for intelligent, automated tools to assess volume,” said Justin Ryea, Senior Director of Product Management at Viz.ai. “This latest tool, alongside existing intracerebral hemorrhage measurements, reflects our commitment to expanding the Viz Neuro Suite to support high-impact neurological conditions.”