FDA Clears New AI Tool for Diagnosing Subdural Hemorrhage
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.
Could Lymph Node Distribution Patterns on CT Improve Staging for Colon Cancer?
April 11th 2025For patients with microsatellite instability-high colon cancer, distribution-based clinical lymph node staging (dCN) with computed tomography (CT) offered nearly double the accuracy rate of clinical lymph node staging in a recent study.
Could Ultrafast MRI Enhance Detection of Malignant Foci for Breast Cancer?
April 10th 2025In a new study involving over 120 women, nearly two-thirds of whom had a family history of breast cancer, ultrafast MRI findings revealed a 5 percent increase in malignancy risk for each second increase in the difference between lesion and background parenchymal enhancement (BPE) time to enhancement (TTE).
AMA Approves Category III CPT Codes for AI-Enabled Perivascular Fat Analysis from CT Scans
April 9th 2025Going into effect in 2026, the new CPT codes may facilitate increased adoption of the CaRi-Heart software for detecting coronary inflammation from computed tomography scans pending FDA clearance of the technology.
