FDA Clears AI Assessment of Ischemic Core Volume on CT with Brainomix 360 Platform

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.