To evaluate the role of artificial intelligence (AI) in cancer histopathology, focusing on FDA-approved whole-slide image (WSI) solutions and best practices for development and validation.
Approach:
Evaluation of AI in Histopathology: An in-depth evaluation of AI applications in cancer histopathology through FDA-approved and European Conformity-marked whole-slide image In Vitro Diagnostic Medical Devices.
Regulatory Guidelines Assessment: Evaluation of regulatory guidelines from FDA and UK Government documentation, emphasizing patient safety.
Comparison with Research-Only Solutions: Contrasting findings with state-of-the-art research-only AI histopathology pipelines.
Key Findings:
Only four FDA-approved whole-slide image cancer solutions exist for a narrow range of applications.
AI in digital histopathology is still in an emerging state.
Approved products integrate efficiently into existing clinical decision-making frameworks.
Challenges remain for direct clinical adoption of AI outside research settings.
Interpretation:
Limitations:
Limited number of FDA-approved solutions.
Challenges in validating agentic and generative AI for clinical use.
Regulatory concerns regarding full automation in high-risk decisions.
