Viz.ai said the Viz Subdural Hematoma (SDH) artificial intelligence (AI) algorithm provides automatic detection of acute and chronic subdural hemorrhages, facilitating timely triage and treatment of patients.
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.
“Acute (subdural hemorrhages) require urgent intervention. Therefore, prompt notification will allow us to improve outcomes in emergent cases. Chronic (subdural hemorrhages) have a very different pathway and having an algorithm that identifies both can allow us to take better care of our patients,” noted Dr. Davies, an 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.”
References
1. Neifert SN, Chaman EK, Hardigan T, et al. Increases in subdural hematoma with an aging population – the future of Amerivcan cerebrovascular disease. World Neurosurg. 2020;141;e166-e174.
2. Viz.ai. Viz.ai receives FDA 510(k) clearance for Viz SDH. Available at: https://www.viz.ai/press-release/viz-ai-receives-fda-510-k-clearance-for-viz-sdh . Published July 27, 2022. Accessed August 1, 2022.
FDA Clears Enhanced MRI-Guided Laser Ablation System
June 5th 2025An alternative to an open neurosurgical approach, the Visualase V2 MRI-Guided Laser Ablation System reportedly utilizes laser interstitial thermal therapy (LITT) for targeted soft tissue ablation in patients with brain tumors and focal epilepsy.
Can Abbreviated MRI Have an Impact in Differentiating Intraductal Papilloma and Ductal Secretion?
June 3rd 2025For patients with inconclusive ultrasound results, abbreviated breast MRI offers comparable detection of intraductal papilloma as a full breast MRI protocol at significantly reduced times for scan acquisition and interpretation, according to a new study.
Can AI Assessment of PET Imaging Predict Treatment Outcomes for Patients with Lymphoma?
June 2nd 2025The use of adjunctive AI software with pre-treatment PET imaging demonstrated over a fourfold higher likelihood of predicting progression-free survival (PFS) in patients being treated for lymphoma, according to a new meta-analysis.