Claimed to be the only SDH-specific AI-powered platform, Viz SDH is capable of identifying acute and chronic subdural bleeds and rapidly notifying the care team to help mobilise an immediate intervention, if necessary
Viz SDH approved by the US FDA. (Credit: National Cancer Institute on Unsplash)
Viz.ai, an AI-powered disease detection and intelligent care coordination platform, has received the US Food and Drug Administration (FDA) 510(k) approval for its Viz Subdural (SDH).
The Viz SDH algorithm, which leverages AI technology to detect subdural haemorrhage automatically, enables physicians to triage patients, and deliver optimal care.
According to the company, subdural hematoma (SDH) is anticipated to become the most common neurosurgical diagnosis by 2030.
However, acute and chronic subdural haemorrhages require a different type of intervention that involves various clinical pathways, some needing rapid attention from the care team.
The company claimed that its Viz SDH is the only AI-powered platform that detects SDH and coordinates the care teams.
Its new solution is capable of identifying acute and chronic subdural bleeds, and rapidly notifying the care team to help mobilise an immediate intervention, if necessary, said Viz.
State University of New York (SUNY) neurosurgery and biomedical informatics associate professor Jason Davies said: “Viz SDH allows us to detect both acute and chronic subdural haemorrhages 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. The Viz.ai algorithm ensures that patients are quickly identified and routed to the appropriate therapy.”
In a multi-centre clinical trial involving more than 500 patients, AI technology showed a high level of accuracy, achieving 94% sensitivity and 92% specificity.
The Viz SDH module joins the growing number of FDA-approved AI algorithms on the enterprise-wide Viz Platform.
Viz Platform is clinically validated and reimbursed by Medicare and will save time, improve patient outcomes and access to care, said the company.
Viz.ai chief clinical officer Jayme Strauss said: “Subdural haemorrhages 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 haemorrhage and expediting communications and image sharing to improve the clinician workflow and more efficiently and effectively treat patients experiencing subdural haemorrhages.
“The algorithm is very sensitive and specific, significantly increasing the number of subdural haemorrhages detected and ensuring patients receive the necessary follow-up from this potentially life-threatening disease.”
Earlier this year, Viz.ai secured the US Food and Drug Administration (FDA) approval for an AI-powered algorithm to identify suspected cerebral aneurysms.