UK-based medical imaging company Brainomix has received US Food and Drug Administration (FDA) approval for Brainomix 360 to enhance stroke care through AI insights.
The AI-powered stroke imaging solution allows physicians to assess ischemic core volume using universally available non-contrast CT (NCCT) images.
It offers expert-level insights to improve treatment decisions and patient transfers across stroke networks.
The core volume feature has been validated in a study by leading stroke centres in the US.
The results indicate that the feature provides assessments equivalent to those derived from CT Perfusion and MRI, addressing a critical unmet need in stroke triage.
Brainomix 360 allows physicians to use routine brain scans to make informed decisions.
Brainomix CEO and co-founder 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.”
Brainomix 360 is said to be the only AI stroke imaging tool that has an impact on stroke treatment rates.
Based on a real-world evaluation incorporating data from over 450,000 patients over three years, Brainomix 360 resulted in a more than 50% increase in mechanical thrombectomy rates.
The solution underscores the potential of AI in advancing stroke care, expanding access to life-changing treatments and improving outcomes for patients worldwide.
Mehdi Bouslama from Broward Health co-authored a study, together with Raul Nogueira and colleagues from Emory University, validating Brainomix’s NCCT core volume.
Mehdi Bouslama 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 centres 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.”
University of California, San Francisco professor of neuroradiology Kambiz Nael co-authored a study, which showed that Brainomix NCCT is comparable to CT Perfusion.
Kambiz Nael said: “Our results demonstrate the ability of this algorithm to estimate ischemic core volumes from NCCT with similar performance to CTP and may be an attractive alternative in centres without ready access to advanced imaging modalities.”
