Objective:

To systematically evaluate commercially available AI tools for detecting and quantifying intracerebral hemorrhage (ICH) using non-contrast computed tomography (NCCT), highlighting the clinical significance of accurate detection and quantification.

Key Findings:

• A total of 22 studies were included in the review, providing a robust dataset for analysis.
• Six of nineteen manufacturers provided publication lists for evaluation, indicating varying levels of transparency.
• Identified 11 eligible AI products after thorough screening from FDA and EUDAMED databases, highlighting the current landscape of available tools.

Interpretation:

The review highlights advancements in AI tools for ICH detection and volume quantification, emphasizing the critical need for systematic evaluation of their performance and regulatory compliance to ensure safe clinical application.

Limitations:

• Limited availability of comprehensive data from the EUDAMED database may restrict the generalizability of findings.
• Exclusion of non-FDA or CE-approved tools may limit the scope of findings, potentially overlooking innovative solutions.

Conclusion:

The systematic review provides valuable insights into the current landscape of AI tools for ICH, emphasizing the importance of regulatory approval, clinical validation, and the need for ongoing research to enhance these technologies.