Viz.ai announced today that it received FDA 510(k) clearance for its Viz Aneurysm algorithm for detecting suspected cerebral aneurysms.
San Francisco-based Viz.ai’s new algorithm uses artificial intelligence (AI) to detect the aneurysms, offering hospital systems a way to ensure that, once detected, the patients are captured and the aneurysm workflow across an entire health system is standardized.
According to a news release, the standardized workflow allows for appropriate follow-up care and significant financial benefits for hospital systems and payers. The company touts Viz Aneurysm as a first-of-its-kind population health tool for facilitating population screening and enhanced care management.
The company touted a University of Toronto study that tested the accuracy of the Viz Aneurysm platform using 528 CTAs with 674 aneurysms broadly distributed across the cerebral vascular territories. Analysis demonstrated 94% accuracy using the algorithm.
“Viz Aneurysm has the potential to significantly increase the number of aneurysms detected and clinically followed,” Viz.ai Chief Clinical Officer Jayme Strauss said in the release. “The combination of detection with an ability to schedule patients for neurovascular specialist follow-up is an important advancement for aneurysm patients, helping patients obtain the necessary follow-up from this potentially deadly disease and driving improved outcomes on the population health level.”