Viz Subdural Hematoma (SDH), a new artificial intelligence (AI)-powered algorithm for diagnosing subdural hemorrhages, has garnered 510(k) clearance from the Food and Drug Administration (FDA), according to Viz.ai, the manufacturer of the module. Noting a rising incidence of subdural hematomas, Viz.ai said the SDH algorithm demonstrated sensitivity and specificity rates of 94 and 92 percent respectively in a multicenter trial of over 500 patients.1,2 "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," maintained Jayme Strauss, the chief clinical officer at Viz.ai. The company emphasizes that Viz SDH is currently the only AI-powered platform specifically geared to identifying and differentiating between acute and chronic subdural hemorrhages. Jason Davies, M.D., Ph.D., said this is a key benefit given the different treatment pathways for these conditions.

Viz.ai announced it has received U.S. Food and Drug Administration (FDA) 501(k) clearance for Viz SDH, which uses artificial intelligence (AI) to detect subdural hemorrhage (SDH). By detecting SDH automatically, Viz SDH allows physicians to triage patients effectively and deliver care, according to the company. Viz.ai notes that subdural hemorrhage is projected to become the most common neurosurgical diagnosis by 2031, and global clinical trials are investigating new treatments to address this disease. Viz SDH has the capability to identify acute and chronic subdural bleeds and notify the care team in the event of a necessary immediate intervention, according to Viz.ai.