Intracranial haemorrhage triage on non-contrast head CT

Under reviewActive deploymentDeveloping evidence

Undergoing in-depth clinical, technical and governance review.

Flags head CT studies suspected of acute intracranial haemorrhage and re-prioritises them in the radiology worklist to shorten time-to-diagnosis.

Plain-language summary

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Clinical context

Clinical problem: Detect a condition
Point of care: Triage
Nature of AI output: An alert
Clinical specialty: Radiology
Care setting: Emergency department
Patient population: Adult patients undergoing non-contrast head CT in the emergency department and inpatient setting.
Intended use: Flags head CT studies suspected of acute intracranial haemorrhage and re-prioritises them in the radiology worklist to shorten time-to-diagnosis.

Technology

Deployment

Regulatory & governance

EU AI Act risk tier: High-risk
High-risk basis: Annex I — medical device
Medical device: Yes
EU MDR class: Class IIa
CE marking: CE marked
FDA status: 510(k) cleared
ISO 14971 risk class: Medium
GDPR processing basis: Public interest
GDPR DPIA: Completed
Data identifiability: Pseudonymised
Explainability method: Post-hoc
Human oversight model: Worklist prioritisation only — the radiologist makes and signs every diagnostic report.

NICE evidence standards

Performance summary

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Studies and evaluations attached to this use case.

Prospective observational
Time saved: 32
Population: ED workflow, time-to-notification (minutes)
Retrospective validation
AUC / AUROC: 0.96
Population: Emergency head CT, 8k studies

Deploying organisation: [demo] Charité – Universitätsmedizin Berlin · Hospital / health system · Germany
AI vendor: [demo] Aidoc · Israel
Product name: BriefCase ICH