FDA Clears New AI Tool for Diagnosing Subdural Hemorrhage

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.