FDA Clears Artificial Intelligence-Assisted Imaging System for Cerebral Aneurysm Detection

 The Food and Drug Administration (FDA) gave 510(k) clearance for an artificial intelligence (AI) solution (Viz Aneurysm; Viz.ai, San Francisco, CA) for cerebral aneurysm detection. This imaging solution uses an algorithm to analyze brain imaging and identify cerebral aneurysms, to ensure patients are identified and promote standardized aneurysm workflow across an entire health system. 

Cerebral aneurysm detection and coordination of care for people with aneurysms, and care pathways can be complex. A study from the University of Toronto testing the accuracy of the AI solution showed the area under the curve (AUC) was 0.85 and 0.88 for unruptured and ruptured aneurysms, respectively. After training on a larger data set of 2,400 normal CTAs, the sensitivity for unruptured and ruptured improved to AUC of 0.93 for unruptured and 0.94 for ruptured aneurysms. For large aneurysms (>7 mm), there was 91.5% specificity at 90% sensitivity. 

“[Aneurysms] can be often missed because they require a very methodical diagnostic approach. The Viz.ai aneurysm algorithm was able to detect cerebral aneurysms in consecutive CTAs. 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,” concluded Dr. Vitor Mendes Pereira, director of Endovascular Research and Innovation, University of Toronto.
 
“Viz Aneurysm has the potential to significantly increase the number of aneurysms detected and clinically followed,” said Jayme Strauss, chief clinical officer, Viz.ai. “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.”
 
The cerebral aneurysm detection software module can be added onto the Viz Intelligent Care Coordination Platform, a neuroimaging analysis platform that is clinically validated and reimbursed by Medicare.