Viz.ai receives FDA nod for brain AI software

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Viz.ai announced it has received U.S. Food and Drug Administration (FDA) 501(k) clearance for Viz SDH, which uses artificial intelligence (AI) to detect subdural hemorrhage (SDH).

By detecting SDH automatically, Viz SDH allows physicians to triage patients effectively and deliver care, according to the company. Viz.ai notes that subdural hemorrhage is projected to become the most common neurosurgical diagnosis by 2031, and global clinical trials are investigating new treatments to address this disease.

Viz SDH has the capability to identify acute and chronic subdural bleeds and notify the care team in the event of a necessary immediate intervention, according to Viz.ai.

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