Brainomix has announced the US Food and Drug Administration (FDA) clearance of a novel and patented feature that enables physicians to assess ischaemic core volume from universally available non-contrast computed tomography (NCCT) images through the Brainomix 360 Stroke solution.
The core volume feature has been studied and validated by leading US stroke centres, with results demonstrating equivalency to CT perfusion (CTP) and magnetic resonance imaging (MRI)-derived core volume assessments. According to a Brainomix press release, this addresses a “longstanding unmet need” in stroke triage, enabling physicians across stroke networks to access expert-level insights to improve decision-making for the treatment and transfer of patients using routinely available brain scans.
The release goes on to state that Brainomix 360 is the only stroke artificial intelligence (AI) imaging tool with a demonstrated impact on stroke treatment rates. Results from the largest real-world evaluation of stroke AI—incorporating national-level data from more than 450,000 patients over a three-year period—found that Brainomix 360 was associated with a >50% increase in mechanical thrombectomy rates, the company claims.
“The ability of Brainomix 360 to estimate ischaemic 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 neurologists and/or neuroradiologists for imaging interpretation, and has the potential to make endovascular therapy more widely available,” said Mehdi Bouslama (Broward Health, Fort Lauderdale, USA), who co-authored a study published in the journal Stroke alongside Raul Nogueira (University of Pittsburgh School of Medicine, Pittsburgh, USA) and colleagues validating Brainomix’s NCCT core volume.
Brainomix’s release details that, in addition, Kambiz Nael (University of California San Francisco [UCSF], San Francisco, USA) has co-authored a study published in the Journal of NeuroInterventional Surgery that found Brainomix NCCT core volumes were comparable to those obtained from concurrent CTP.
“Our results demonstrate the ability of this algorithm to estimate ischaemic core volumes from NCCT with similar performance to CTP and may be an attractive alternative in centres without ready access to advanced imaging modalities,” the study concludes.
Bouslama and Nael will join an upcoming webinar entitled, ‘Imaging the core on NCCT: unlocking stroke insights across networks’, that will take place on Thursday 24 April.
“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,” commented Brainomix chief executive officer (CEO) and co-founder Michalis Papadakis. “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.”
