Viz.ai has achieved a significant regulatory milestone with the U.S. Food and Drug Administration's 510(k) clearance for Viz Subdural Plus, marking the first and only comprehensive AI solution for quantifying subdural hemorrhages on non-contrast computed tomography images. The technology represents a breakthrough in automated measurement capabilities for one of neurosurgery's most challenging conditions.
Automated Precision for Critical Measurements
The Viz Subdural Plus module automatically labels subdural collections and provides precise measurements including volume, thickness, and midline shift. This automation addresses a traditionally manual and time-consuming process that has been prone to variability among clinicians.
"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."
Rising Clinical Need
The timing of this FDA clearance aligns with a growing clinical challenge. Chronic subdural hematoma is projected to become the most common cranial neurosurgical condition in adults, with approximately 60,000 new cases diagnosed annually in the United States by 2030. This increase is driven by the aging population and more widespread use of anticoagulant and antiplatelet medications.
Accurate quantification of subdural collections is essential for evaluating severity, monitoring progression, and informing timely treatment decisions, particularly for patients being considered for middle meningeal artery (MMA) embolization—a minimally invasive treatment option that is increasingly being utilized to reduce recurrence rates.
Platform Integration and Scale
The software is integrated into the Viz.ai One platform, which is currently deployed across 1,800 hospitals and health systems. This extensive network provides immediate access to the new measurement capabilities for a substantial portion of the healthcare system.
"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."
Clinical Impact on Treatment Decisions
The technology's clinical value extends beyond measurement accuracy to treatment optimization. As clinicians increasingly turn to minimally invasive options like MMA embolization to reduce recurrence, tools like Viz Subdural Plus become essential for guiding timely and effective treatment decisions. The automated measurements support standardized assessment protocols and reduce inter-observer variability that can impact treatment planning.
The FDA clearance positions Viz Subdural Plus as a critical tool in the evolving landscape of subdural hematoma management, where precise volume assessment directly influences intervention strategies and patient outcomes.
