Systematic review of commercial artificial intelligence tools for the detection and volume quantification in intracerebral hemorrhage

Category	Detail
Condition	Intracerebral hemorrhage (ICH)
Key Mechanisms	Deep learning (DL)-based AI software applied to non-contrast computed tomography (NCCT) for detection and volumetric segmentation of ICH
Target Population	Patients undergoing NCCT imaging for suspected intracerebral hemorrhage
Care Setting	Radiology and acute care settings requiring rapid triage and imaging interpretation

FDA- and CE-certified AI tools improve speed and accuracy of ICH detection and volume quantification on NCCT.
Systematic review included 22 studies evaluating commercial DL-based ICH detection and segmentation software.
Regulatory database searches revealed 11 FDA-approved AI products meeting inclusion criteria; EUDAMED lacks detailed public data on AI radiology tools.

Utilize FDA- or CE-approved DL-based AI software for detection of ICH on NCCT to enhance diagnostic accuracy and speed.

Incorporate volumetric segmentation outputs from AI tools to assist in patient triage and clinical decision-making.

Regularly update and validate AI software performance using clinical data to maintain reliability and regulatory compliance.

Be aware of potential gaps in regulatory transparency, especially in European databases, and verify software certification status before clinical use.

Patients with suspected or confirmed intracerebral hemorrhage undergoing NCCT imaging

AI tools provide rapid detection and volume measurement to support timely clinical interventions and improve radiological workflow efficiency.

Select AI software tools that are currently FDA- or CE-approved and utilize deep learning technology for ICH detection and volumetric analysis.
Integrate AI outputs into clinical workflows to prioritize urgent cases and facilitate prompt notification of critical findings.
Conduct systematic literature and regulatory database reviews to inform selection of AI tools with validated clinical performance.
Remain vigilant about software version updates and regulatory status to ensure ongoing compliance and optimal patient care.

Clinical Scorecard: Comprehensive Analysis of Commercial AI Solutions for Identifying and Measuring Volume in Intracerebral Hemorrhage