FDA clearances confirmed for the flagship 360 e-ASPECTS software and a separate ‘Core Volume’ feature.
Clinical evidence
Vendor-supported
Press releases (PR Newswire, DAIC, Applied Radiology); vendor-funded real-world evaluations and a Lancet Digital Health study on thrombectomy-rate impact (co-authored/promoted by Brainomix — treat as vendor-adjacent, not fully independent).
Independent
Mair G, White P, Bath PM, Muir KW, Al-Shahi Salman R, et al., ‘External Validation of e-ASPECTS Software for Interpreting Brain CT in Stroke’, Annals of Neurology, 2022;92(6):943-957 (PMID 36053916). Independent academic authors (UK/Germany), no Brainomix conflict of interest declared. n=4,100 patients: ischemia detection accuracy 71% (95% CI 70-72%), hemorrhage detection 85% (95% CI 83-86%); ASPECTS score within 1 point of experts in 69% of cases (n=3,035). Notably higher false-positive rate than expert radiologists (12% vs 2% for ischemia, 14% vs <1% for hemorrhage).
Real-world deployment
No verifiable site count found in this research pass.
Interoperability
European status
Editorial verdict
Limits and uncertainties
Independent validation (Mair et al. 2022) found a meaningfully higher false-positive rate than expert radiologists — an adjunct decision-support tool, not a replacement for radiologist review.
This profile is not medical advice or an endorsement. Hospitals should perform their own due diligence (regulatory compliance, GDPR, cybersecurity, integration, local clinical validation). How we evaluate
Every profile documents the precise indication, regulatory status, vendor-supported and independent evidence, real-world deployment, limits and dated sources.
A independent systematic review or prospective multicentre study · B at least one independent peer-reviewed study · C peer-reviewed, vendor-supported · D vendor claims only.