Viz.ai Receives FDA 510(k) Clearance for Viz SDH to Detect Subdural Hemorrhage

July 27, 2022—Viz.ai, developer of an artificial intelligence (AI)–powered disease detection and intelligent care coordination platform, announced it has received FDA 510(k) clearance for Viz Subdural Hematoma (SDH) algorithm, which uses AI to automatically detect subdural hemorrhage and enable physicians to triage patients effectively and deliver optimal care.

According to the company, SDH is projected (Neifert et al, World Neurosurgery. 2020;141:166-174) to become the most common neurosurgical diagnosis by 2030 and multiple global clinical trials are investigating promising new treatments for this disease. However, Viz.ai noted that acute and chronic subdural hemorrhages require different types of intervention via different clinical pathways, with some requiring quick attention from the care team.

Viz SDH is an SDH-specific AI-powered detection and care coordination platform with the ability to identify acute and chronic subdural bleeds, then quickly notify the care team to mobilize in case an immediate intervention is necessary. A multicenter trial of more than 500 patients demonstrated a high degree of accuracy, with the AI achieving a 94% sensitivity and 92% specificity, advised the company.

Jason Davies, MD, who is Associate Professor of Neurosurgery and Biomedical Informatics at the State University of New York at Buffalo, New York, commented in the company’s press release, “Viz SDH allows us to detect both acute and chronic subdural hemorrhages to better identify early treatment pathways. Acute subdurals require urgent intervention. Therefore, prompt notification will allow us to improve outcomes in emergent cases. Chronic subdurals have a very different pathways and having an algorithm that identifies both can allow us to take better care of our patients. The Viz.ai algorithm ensures that patients are quickly identified and routed to the appropriate therapy.”