FDA Clears Ischemic Core Volume Assessment Technology To Assist in Stroke Triage

The Food and Drug Administration (FDA) has granted clearance to a new feature within the Brainomix 360 Stroke (Brainomix, Chicago, IL) imaging platform, according to a statement from the company. Using the newly cleared, patented technology, physicians can evaluate the ischemic core volume from noncontrast CT images. In a press release from Brainomix, the company states that the novel feature enables rapid, artificial intelligence (AI)–driven evaluation of stroke patients without the need for advanced imaging modalities.

The advancement of the Brainomix 360 Stroke platform through the addition of the novel, FDA-cleared ischemic core volume assessment feature addresses a critical need in stroke triage by providing timely and accurate assessments, facilitating informed decisions regarding patient treatment and transfer. According to a statement issued by the company, there was a 50% increase in mechanical thrombectomy rates associated with the implementation of Brainomix 360 Stroke in the real-world setting. Additionally, company materials related to the clearance identify findings of studies conducted by Mehdi Bouslama, MD and Kambiz Nael, MD, published in Stroke and the Journal of Neurointerventional Surgery, which demonstrated the efficacy of the Brainomix 360 Stroke system in estimating ischemic core volume from NCCT images.

Dr. Bouslama, Attending Physician at Broward Health in the Department of Neuroendovascular Surgery and Vascular Neurology, Ft. Lauderdale, FL, said “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.”