FDA clears Viz.ai’s algorithm that detects subdural hemorrhage

Viz.ai announced today that it received FDA 510(k) clearance for its Viz Subdural (SDH) artificial intelligence (AI) algorithm.

San Francisco-based Viz.ai designed its Viz SDH algorithm to use AI to automatically detect subdural hemorrhage, enabling physicians to triage patients effectively and deliver optimal care.

The company said in a news release that its Viz SDH represents the only 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.

“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,” Dr. Jason Davies, associate professor of neurosurgery and biomedical informatics at the State University of New York (SUNY) at Buffalo, said in the release. “The Viz.ai algorithm ensures that patients are quickly identified and routed to the appropriate therapy.”

Viz.ai said that a multi-center trial of over 500 patients demonstrated a high degree of accuracy with Viz SDH, as the AI achieved a 94% sensitivity and 92% specificity.

The module is the latest of Viz.ai’s FDA-cleared algorithms to be added to the enterprise-wide Viz Platform, which is clinically validated and reimbursed by Medicare and proven to save time, improve patient outcomes and access to care.

“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,” Viz.ai Chief Clinical Officer Jayme Strauss said. “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.”

Original Article: (https://www.massdevice.com/fda-clears-viz-ais-algorithm-that-detects-subdural-hemorrhage/)