Press & News

Jul 27, 2022

10 min Receives FDA 510(k) Clearance for Viz™ SUBDURAL (SDH)

AI-powered Viz SUBDURAL (SDH) automatically detects subdural hemorrhage, enables effective triage and optimal care

SAN FRANCISCO – July 27, 2022 –, the leading AI-powered disease detection and intelligent care coordination platform, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz Subdural (SDH). The Viz SDH algorithm uses artificial intelligence to automatically detect subdural hemorrhage, enabling physicians to triage patients effectively and deliver optimal care.

Subdural Hematoma (SDH) is projected to become the most common neurosurgical diagnosis by 20301, and multiple global clinical trials are investigating promising new treatments for this disease. However, acute and chronic subdural hemorrhages require different types of intervention via different clinical pathways, with some requiring quick attention from the care team. Viz SDH is the only SDH-specific AI-powered detection and care coordination platform with the ability to identify acute and chronic subdural bleeds, then quickly notify the care team to mobilize in case an immediate intervention is necessary.

“Viz SDH allows us to detect both acute and chronic subdural hemorrhages 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,” said Jason Davies, MD, PhD,  Associate Professor of Neurosurgery and Biomedical Informatics at the State University of New York (SUNY) at Buffalo. “The algorithm ensures that patients are quickly identified and routed to the appropriate therapy.”

A multi-center trial of over 500 patients demonstrated the high degree of accuracy, with the AI achieving a 94% sensitivity and 92% specificity2.

“Subdural hemorrhages 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 hemorrhage and expediting communications and image sharing to improve the clinician workflow and more efficiently and effectively treat patients experiencing subdural hemorrhages,” said Jayme Strauss, chief clinical officer, “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.”

The Viz SDH module is another of the fast growing number of FDA cleared AI algorithms on the enterprise-wide Viz Platform, which is clinically validated and reimbursed by Medicare and proven to save time, improve patient outcomes and access to care.


Neifert, S.N., Chaman, E.K., Hardigan, T., (2020). Increases in subdural hematoma with an aging population- the future of cerebrovascular disease. World Neurosurgery, 141, 166-174.
 Woodward et al. Official FDA Validation Study for Viz SDH

About, Inc. is the pioneer in the use of AI algorithms and machine learning to increase the speed of diagnosis and care, covering more than 220 million lives across 1,400+ hospitals and health systems in the U.S. and Europe. The AI-powered Viz Platform is an intelligent care coordination solution that identifies more patients with a suspected disease, informs critical decisions at the point of care, and optimizes care pathways and helps improve outcomes. Backed by real-world clinical evidence, the Viz Platform delivers significant value to patients, providers, and pharmaceutical and medical device companies.