Viz.ai Nabs FDA Nod for Intracerebral Hemorrhage Detection Algorithm

Viz.ai, an AI company focused on disease detection and intelligent care coordination, recently announced the FDA 510(k) clearance of its algorithm, Viz ICH Plus. The algorithm automates the process of identifying, labeling, and quantifying the volume of “segmentable brain structures on non-contrast computed tomography (NCCT) images,” according to the press release.

Indicated for analyzing intracranial hyperdensities, lateral ventricles, and midline shift, as well as providing measurements of brain bleeds for timely and informed treatment, Viz ICH Plus enhances the standard analog decision-making process and approach to intracerebral hemorrhage cases.

As intracerebral hemorrhage cases account for up to 15% of all strokes, accurate volume measurements of brain bleeds remain crucial for understanding case severity, monitoring progression, and planning treatment strategies. The Viz ICH Plus software is available on the AI-powered Viz.ai One, a platform that the company says is clinically validated, saves time, improves patient outcomes, and increases access to life-saving treatments.

"At Viz.ai, our mission is rooted in advancing healthcare through innovation,” said Jayme Strauss, chief clinical officer at Viz.ai, in the release. “Viz ICH Plus exemplifies our dedication to enhancing patient care by leveraging technology. We are excited to introduce a product that bridges the gap between AI capabilities and improved patient outcomes."