FDA Clears AI-Assisted Imaging Analysis Software for Subdural Hemorrhage Triage

The Food and Drug Administration (FDA) has cleared an artificial intelligence (AI)-powered neuroimaging software package (Viz Subdural (SDH); San Francisco, CA) for diagnosis and triage of subdural hemorrhage.

The software package automatically detects subdural hemorrhage on neuroimaging studies so the health care team can effectively triage the individual patient and provide the best indicated care. Clearance was based on a study in 500 people in which the software identified chronic or acute SDH with 94% sensitivity and 92% specificity in a multi-center trial with 500 participants.
 
“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,” said Jason Davies, MD, PhD, associate professor of Neurosurgery and Biomedical Informatics at the State University of New York (SUNY) at Buffalo. “The Viz.ai algorithm ensures that patients are quickly identified and routed to the appropriate therapy.”

“Subdural hemorrhages are growing in commonality but can present different levels of urgency with different clinical pathways.,” 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.”
 
The Viz SDH module is among several FDA-cleared AI algorithms on the enterprise-wide Viz Platform, which is clinically validated and reimbursed by Medicare.