FDA Clears AI Algorithm for Intracerebral Hemorrhage Quantification

Viz.ai has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz ICH Plus, an algorithm that automates the process of identifying, labeling, and quantifying the volume of segmentable brain structures on non-contrast computed tomography (NCCT) images. The Viz ICH Plus software analyzes intracranial hyperdensities, lateral ventricles and midline shift, providing volume measurements of brain bleeds for timely and informed treatment decisions.
 
“The ability and mobility to obtain accurate and quantifiable measurements of intracerebral hemorrhages through Viz ICH Plus significantly enhances our decision-making process,” said Peter Kan, M.D., professor and chair of the Neurosurgery Department at the University of Texas Medical Branch. “This technology, which marries precision with AI, is poised to transform how we approach intracerebral hemorrhage cases.”
 
Intracerebral hemorrhage accounts for up to 15% of all strokes and has high morbidity and mortality rates, demanding swift response. Accurate volume measurements of brain bleeds are crucial for assessing case severity, monitoring progression, and planning treatment strategies. Radiologists, neurologists and neurosurgeons can incorporate Viz ICH Plus seamlessly into their workflows and automate the manual process of measuring brain bleeds. The Viz ICH Plus software is available on the AI-powered Viz.ai One solution, an enterprise platform that is clinically validated, saves time, improves patient outcomes, and increases access to life-saving treatments across more than 1,500 U.S. hospitals.
 
“At Viz.ai, our mission is rooted in advancing healthcare through innovation,” Viz.ai Chief Clinical Officer Jayme Strauss stated. “We are excited to introduce a product that bridges the gap between AI capabilities and improved patient outcomes.”
 
Viz.ai uses artificial intelligence algorithms and machine learning to increase the speed of diagnosis and care. The AI-powered Viz.ai One is an intelligent care coordination solution that identifies more patients with a suspected disease, informs critical decisions at the point of care, and optimizes care pathways, and helps improve outcomes. Backed by real-world clinical evidence, Viz.ai One delivers value to patients, providers, and pharmaceutical and medical device companies.