The Food and Drug Administration (FDA) has granted clearance for a new feature in Brainomix’s 360 Stroke solution, allowing physicians to evaluate ischemic core volume from universally available non-contrast computed tomography (NCCT) images.
US stroke centres have studied and validated this patented feature, showing equivalency to core volume assessments derived from CT perfusion and magnetic resonance imaging (MRI).
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The new feature addresses a critical gap in stroke triage by providing medical professionals throughout stroke networks with “expert-level” insights.
These insights aim to enhance the decision-making process regarding patient treatment and transfer, relying on routine brain scans.
Brainomix 360 claims to be the sole stroke AI imaging tool that displayed an influence on stroke treatment rates.
Brainomix CEO and co-founder Dr Michalis Papadakis said: “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.
“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.”
A substantial study encompassing data from more than 450,000 subjects across three years highlighted that the use of Brainomix 360 was linked to an increase of over 50% in mechanical thrombectomy rates.
Last month, the company completed a Series C funding round, raising £14m ($18m) to support the deployment of the Brainomix 360 Stroke solution across the US to further its commercial expansion.
