FDA Clears AI Assessment of Ischemic Core Volume on CT with Brainomix 360 Platform
For patients with acute ischemic stroke, research has demonstrated that automated assessment of ischemic core volume on brain CT scans via the Brainomix 360 software is equivalent to that derived from CT perfusion.
The Food and Drug Administration (FDA) has granted 510(k) clearance for artificial intelligence (AI)-enabled assessment of ischemic core volume on non-contrast computed tomography (CT) scans with Brainomix 360 software.1
Brainomix, the developer of the software, said the ischemic core volume feature with the Brainomix 360 platform is a “critical advancement in stroke imaging” that facilitates timely evaluation, triage, and treatment.1
Recently published research has demonstrated similar ischemic core volumes between Brainomix 360 assessment and CT perfusion (20.4 mL vs. 19.9 mL) in patients with acute ischemic stroke.2
“The ability of Brainomix 360 to estimate ischemic core volumes in a reliable and reproducible manner with a similar performance to CT perfusion represents an attractive alternative in centers without ready access to either advanced imaging modalities or stroke neurologist and/or neuroradiologist for imaging interpretation and has the potential to make endovascular therapy more widely available,” noted Mehdi Bouslama, M.D., an attending physician in neuroendovascular surgery and vascular neurology with Broward Health in South Florida.
References
1. Brainomix. Brainomix advances stroke care with landmark FDA clearance. PR Newswire. Available at: https://www.prnewswire.com/news-releases/brainomix-advances-stroke-care-with-landmark-fda-clearance-302421952.html . Published April 8, 2025. Accessed April 8, 2025.
2. Shahrouki P, Kihira S, Tavaakol E, et al. Automated assessment of ischemic core on non-contrast computed tomography: a multicenter comparative analysis with CT perfusion. J Neurointerv Surg. 2024;16(12):1288-1293.
Could Lymph Node Distribution Patterns on CT Improve Staging for Colon Cancer?
April 11th 2025For patients with microsatellite instability-high colon cancer, distribution-based clinical lymph node staging (dCN) with computed tomography (CT) offered nearly double the accuracy rate of clinical lymph node staging in a recent study.
Study Suggests AI Software May Offer Standalone Value for X-Ray Detection of Pediatric Fractures
April 9th 2025Artificial intelligence (AI) software demonstrated a 92 percent sensitivity for detecting fractures in a study involving over 1,600 X-rays from a tertiary pediatric emergency department.
What New Research Reveals About Novice Use of AI-Guided Cardiac Ultrasound
April 4th 2025In a study recently presented at the American College of Cardiology (ACC) conference, researchers found that novice use of AI-guided cardiac ultrasound after an AI-enabled electrocardiogram increased the positive predictive value for reduced left ventricular ejection fraction (LVEF) or aortic valve stenosis by 33 percent.
