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FDA Grants Clearance to's AI Algorithm for Intracerebral Hemorrhage Quantification

Friday, February 09, 2024, a leading provider of AI-driven disease detection and care coordination solutions, has recently obtained FDA 510(k) clearance for its software, Viz ICH Plus. This innovative algorithm automates the identification, labeling, and quantification of segmentable brain structures on non-contrast computed tomography (NCCT) images. Specifically designed for analyzing intracranial hyperdensities, lateral ventricles, and midline shift, Viz ICH Plus delivers crucial volume measurements of brain bleeds to aid in prompt treatment decisions.

Accurate volume assessments of brain bleeds are paramount in addressing intracerebral hemorrhage cases, which account for up to 15% of all strokes and are associated with high morbidity and mortality rates. Viz ICH Plus streamlines the decision-making process by providing precise measurements, facilitating better patient outcomes. Its integration into the workflows of radiologists, neurologists, and neurosurgeons simplifies and automates the manual measurement process, enhancing efficiency and accuracy.

Viz ICH Plus is accessible through the AI-powered One™ solution, a validated platform deployed in over 1,500 hospitals across the United States. By saving time and improving access to life-saving treatments, this technology plays a significant role in transforming the management of intracerebral hemorrhage cases.


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