Viz.ai Wins FDA Nod for Subdural Measurements

Viz.ai has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz Subdural Plus, the first and only comprehensive solution to quantify the size of collections like subdural hemorrhages (SDH) in the subdural space on non-contrast computed tomography (NCCT) images.

The module supports clinical decisions by automatically labeling subdural collections and reporting measurements like volume, thickness, and midline shift. Accurate quantification of subdural collections is essential to evaluate severity, monitor progression, and inform timely treatment—especially for patients being considered for MMA embolization.

Viz Subdural Plus supports clinicians in streamlining subdural collection analysis by automating what has traditionally been a manual and time-consuming measurement process. The software is available as part of the Viz.ai One platform, which is currently deployed across 1,800 hospitals and health systems.

“Viz Subdural Plus introduces a new level of precision in diagnosing and monitoring subdural hemorrhage,” said David J. Altschul, MD, Division Chief 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. 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.”

Earlier this week, the company also crafted a multi-year partnership with Sanofi and Regeneron to deploy and evaluate an artificial intelligence (AI)-powered workflow solution for chronic obstructive pulmonary disease (COPD).

“With an aging population, the incidence of chronic subdural hematomas is rising, and so is the need for intelligent, automated tools to assess volume when deciding on the appropriate intervention, such as MMA embolization,” said Justin Ryea, Senior Director of Product Management at Viz.ai. “Viz Subdural Plus, along with intracerebral hemorrhage measurements, exemplify how we’re expanding our capabilities in our market-leading Viz Neuro Suite to address high-impact conditions, reduce variability in care, and drive better outcomes at scale.”