Brainomix Wins FDA Nod to Broaden Use of Stroke AI

Brainomix, a company focused on artificial intelligence (AI)-powered stroke imaging, has earned U.S. Food and Drug Administration (FDA) clearance for a new feature for its Brainomix 360 stroke solution.

The new, patented feature lets physicians assess ischemic core volume from universally available non-contrast CT (NCCT) images through Brainomix 360.

The company said the core volume feature was validated by leading U.S. stroke centers and showed equivalency to CT perfusion and MRI-derived core volume assessments. This addresses an unmet need in stroke triage, allowing expert-level insights to be gleaned from routinely available brain scans.

According to the company, Brainomix 360 is the only stroke AI imaging tool with a demonstrated impact on rates of stroke treatment. A real-world evaluation of stroke AI with national-level data from over 450,000 patients over three years found Brainomix 360 was related to an over 50% increase in mechanical thrombectomy rates.

“This key expansion of our Brainomix 360 platform marks a critical advancement in stroke imaging and reinforces our mission to transform stroke care through cutting-edge technology,” said Dr. Michalis Papadakis, co-founder and CEO at Brainomix. “Brainomix 360 empowers stroke teams by unlocking real-time, high-precision insights that can help expand patient access to life-changing treatments, including both thrombolysis and mechanical thrombectomy, for use up to 24 hours after stroke onset.”

In February, Brainomix and Medtronic Neurovascular began a partnership to boost stroke care for Western European patients by integrating AI solutions into clinical practices.