Brainomix earns new FDA nod for stroke imaging tech

Brainomix announced today that it received FDA clearance for a new feature within its 360 Stroke solution for AI-powered stroke imaging.

FDA clearance covers a novel, patented feature that enables physicians to assess ischemic core volume from universally available non-contrast CT (NCCT) images through the 360 Stroke platform. Studied and validated by leading U.S. stroke centers, the new feature demonstrated equivalency to CT perfusion and MRI-derived core volume assessments.

Powered by state-of-the-art AI algorithms, 360 Stroke provides real-time interpretations of brain scans. It aids in the treatment and transfer decisions for stroke patients, according to the company.

Brainomix says its latest feature addresses a longstanding unmet need in stroke triage. It enables physicians across stroke networks to access expert-level insights for decision-making using routinely available brain scans.

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