Viz.ai has secured US Food and Drug Administration (FDA) 510(k) clearance for its Viz Subdural Plus module, marking a significant advancement in AI-driven healthcare solutions.
Viz Subdural Plus is the first tool to offer comprehensive quantification of subdural haemorrhages (SDH) on non-contrast computed tomography (NCCT) images.
The module enhances the precision and reliability of clinical decision-making.
The Viz Subdural Plus module helps clinicians by automatically labelling and measuring subdural collections, including volume, thickness, and midline shift.
It streamlines the effective evaluation of haemorrhage severity and progression, which has traditionally been a laborious manual process, and is crucial for timely treatment decisions.
Viz.ai product management senior director Justin Ryea said: “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 embolisation.
“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.”
The Viz Subdural Plus module is part of the Viz.ai One platform, which is operational in 1,800 hospitals and health systems.
Viz.ai One is an intelligent care coordination solution that identifies patients with a suspected disease, informs critical decisions, optimises care pathways and helps improve outcomes.
Supported by real-world clinical evidence, the platform delivers significant value to patients, providers, and pharmaceutical and medical device companies
The platform integrates machine learning algorithms to analyse data from imaging, electronic health records (EHR), and other tests, and real-time insights for diagnosis and treatment.
Montefiore Health System cerebrovascular neurosurgery division chief David Altschul said: “Viz Subdural Plus introduces a new level of precision in diagnosing and monitoring subdural haemorrhage.
“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 embolisation to reduce recurrence, tools like Viz Subdural Plus are essential to guiding timely and effective treatment.”
Earlier this year, Viz.ai partnered with Guardant Health, a precision oncology company, to improve lung cancer detection, diagnosis, and treatment.
The collaboration aims to promote timely biomarker testing with the Guardant360 CDx liquid biopsy, thereby improving early diagnosis and treatment decisions for lung cancer patients.
