AI-Powered Algorithm Gets FDA 501(k) Clearance for Detection of Subarachnoid Hemorrhages

Subarachnoid hemorrhages reportedly affect nearly 30,000 Americans each year and have a 40 percent mortality rate. However, Viz ANEURYSM, a new artificial intelligence (AI)-powered algorithm, may improve the diagnosis of subarachnoid hemorrhages and facilitate more timely intervention and follow-up, according to the manufacturer Viz.ai.

Viz ANEURYSM, which recently garnered 510(k) clearance from the Food and Drug Administration (FDA), was the subject of a 2020 study presented at the International Stroke Conference by researchers from the University of Toronto. Researchers assessed the use of the algorithm on 528 computed tomography angiography (CTA) scans that revealed a total of 674 aneurysms. Viz.ai said the study revealed a 94 percent accuracy rate for Viz ANEURYSM.

“(Aneurysms) can often be missed because they require a very methodical diagnostic approach,” noted lead study author Vitor Mendes Pereira, MSc, MD, the director of endovascular research and innovation at the University of Toronto. “The model has demonstrated that a deep learning AI algorithm can achieve clinically useful levels of accuracy for clinical decision support and will help us to improve how we help aneurysm patients.”

Clinicians can add the Viz ANEURYSM module to the Viz Intelligent Care Coordination Platform, which is clinically validated and reimbursed by Medicare, according to Viz.ai.