Brainomix

By Brainomix (Oxford University spin-off)
· UK
Brainomix — Neurovascular / stroke imaging (e-CTA, e-ASPECTS, Core Volume) and lung imaging.
Diagnostic
Radiology
Production
FDA Cleared
Regulatory status
FDA Cleared
Deployment
Production
Clinical role
Adjunct (decision support)
Headquarters
UK
AI type
Diagnostic

Precise indication

Neurovascular / stroke imaging (e-CTA, e-ASPECTS, Core Volume) and lung imaging.

Regulatory status

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.

Sources

https://www.brainomix.com/ ; https://pubmed.ncbi.nlm.nih.gov/36053916/ ; https://www.prnewswire.com/news-releases/brainomix-advances-stroke-care-with-landmark-fda-clearance-302421952.html

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

At a glance
Vendor
Brainomix (Oxford University spin-off)
Headquarters
UK
AI type
Diagnostic
Specialty
Clinical role
Adjunct (decision support)
CE marking
Notified body
EU AI Act
Data hosting
Last verified
Reviewed by
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.

Read the methodology →

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Vendors, authors and clinicians can request a correction. Corrections are dated on the profile.