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April 8, 2025

Brainomix 360 Core Volume Feature for Stroke Imaging Cleared by FDA

April 8, 2025—Brainomix announced the FDA clearance of a feature that enables physicians to assess ischemic core volume from universally available noncontrast CT (NCCT) images through the Brainomix 360 stroke solution, an artificial intelligence (AI) imaging tool.

The core volume feature is intended to enable physicians across stroke networks to access expert-level insights to improve decision-making for treatment and transfer of patients using routinely available brain scans, stated the company.

According to Brainomix, results from a real-world evaluation of stroke AI that incorporated national-level data from > 450,000 patients in a 3-year period found that Brainomix 360 was associated with a > 50% increase in mechanical thrombectomy rates.

Additionally, the company noted that the newly cleared core volume feature has been studied and validated by leading United States stroke centers, with results demonstrating equivalency to CT perfusion and MRI-derived core volume assessments.

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