The US Food and Drug Administration (FDA) has granted 510(k) clearance to Viz.ai for its Viz Subdural Plus module, designed for enhancing clinical decision-making.
It is claimed to be the first solution to quantify the size of collections such as subdural haemorrhages (SDH) in the subdural space on non-contrast computed tomography images.
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This solution automatically labels subdural collections and reports measurements such as thickness, midline shift, and volume.
According to the company, chronic subdural haematoma is anticipated to become the most prevalent cranial neurosurgical condition in the adult population by 2030 in the US, with an estimated 60,000 new cases each year.
The precise assessment of subdural collections is crucial for assessing severity, tracking progression, and guiding timely interventions, particularly for those under consideration for MMA [middle meningeal artery] embolisation.
The software solution is designed to streamline the analysis of subdural collections by automating a process that has traditionally been manual and laborious.
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By GlobalDataIntegrated into the Viz.ai One platform, the software is currently in use in 1,800 health systems and hospitals.
The platform enhances disease detection, supports critical care decisions, and optimises care pathways to improve patient outcomes.
Viz.ai product management senior director Justin Ryea said: “With an ageing 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 embolisation.
“Viz Subdural Plus, along with intracerebral haemorrhage 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.”
The company leverages AI algorithms and machine learning to expedite diagnosis and care in the US and European healthcare systems.
Last year, Viz.ai disclosed new trial data evaluating its AI-powered neurovascular technology that can detect and diagnose various neurological pathologies, including acute ischemic stroke, cryptogenic stroke, unruptured incidental aneurysm (UIA), and brain haemorrhage.
