Sam Brusco, Associate Editor07.28.22
Artificial intelligence (AI)-powered disease detection and intelligent care coordination platform Viz.ai has received U.S. Food and Drug Adminisration (FDA) 510(k) clearance for the Viz Subdural (SDH) algorithm, which uses AI to automatically spot subdural hemorrhage.
According to the company, Viz SDH is the only SDH-specific AI-powered detection and care coordination platform that can identify acute and chronic subdural bleeds, then quickly notify the care team to mobilize should an immediate intervention be needed.
“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 pathway and having an algorithm that identifies both can allow us to take better care of our patients,” Jason Davies, MD, Ph.D., Associate Professor of Neurosurgery and Biomedical Informatics at the State University of New York (SUNY) at Buffalo, told the press. “The Viz.ai algorithm ensures that patients are quickly identified and routed to the appropriate therapy.”
An over-500-patient trial for the technology’s FDA Validation Study showed that the AI achieved 94% sensitivity and 92% specificity.
“Subdural hemorrhages are growing in commonality, but can present different levels of urgency with different clinical pathways. Viz SDH supports physicians by detecting the presence of subdural hemorrhage and expediting communications and image sharing to improve the clinician workflow and more efficiently and effectively treat patients experiencing subdural hemorrhages,” said Jayme Strauss, chief clinical officer, Viz.ai. “The algorithm is very sensitive and specific, significantly increasing the number of subdural hemorrhages detected and ensuring patients receive the necessary follow-up from this potentially life-threatening disease.”
According to the company, Viz SDH is the only SDH-specific AI-powered detection and care coordination platform that can identify acute and chronic subdural bleeds, then quickly notify the care team to mobilize should an immediate intervention be needed.
“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 pathway and having an algorithm that identifies both can allow us to take better care of our patients,” Jason Davies, MD, Ph.D., Associate Professor of Neurosurgery and Biomedical Informatics at the State University of New York (SUNY) at Buffalo, told the press. “The Viz.ai algorithm ensures that patients are quickly identified and routed to the appropriate therapy.”
An over-500-patient trial for the technology’s FDA Validation Study showed that the AI achieved 94% sensitivity and 92% specificity.
“Subdural hemorrhages are growing in commonality, but can present different levels of urgency with different clinical pathways. Viz SDH supports physicians by detecting the presence of subdural hemorrhage and expediting communications and image sharing to improve the clinician workflow and more efficiently and effectively treat patients experiencing subdural hemorrhages,” said Jayme Strauss, chief clinical officer, Viz.ai. “The algorithm is very sensitive and specific, significantly increasing the number of subdural hemorrhages detected and ensuring patients receive the necessary follow-up from this potentially life-threatening disease.”