INSERTING and REPLACING Viz.ai Receives FDA 510(k) Clearance for Viz SDH

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

SAN FRANCISCO--(BUSINESS WIRE)--Insert after fourth paragraph of release: footnote 2.

The updated release reads:

VIZ.AI RECEIVES FDA 510(K) CLEARANCE FOR VIZ SDH

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

Viz.ai, 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 Viz.ai 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% specificity.²

“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, Viz.ai. “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.

About Viz.ai, Inc.

Viz.ai, located in San Francisco, Tel Aviv, Portugal and Amsterdam, pioneered the use of AI algorithms and machine learning to increase the speed of diagnosis and care for a variety of acute and emergent diseases across hospitals and health systems. The Viz Platform is a transformative, intelligent care coordination solution that unifies synchronized care collaboration, high fidelity mobile image viewing, automated workflows and improved visibility at decision-making moments. Viz.ai’s comprehensive neurovascular and vascular AI platform is clinically proven to save time and improve patient outcomes and access to care and is used in more than 1,000 hospitals in the US and EMEA. Viz.ai’s life science portfolio expands the power of the AI-powered Viz Platform to pharmaceutical and medical device companies who are leaning into digital transformation to bring life-saving therapies to market more efficiently. The company was named to the Forbes 2021 Next Billion-Dollar Startups list of the 25 fastest-growing venture-backed startups and has been on the Forbes AI 50 list for three consecutive years. For more information visit viz.ai.

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