Translational AI in whole-slide image cancer histopathology: state of the art and regulatory-approved solutions

1

Only four FDA-approved whole-slide image cancer solutions exist, indicating that AI in digital histopathology is still emerging.
2

AI tools in histopathology can enhance clinical decision-making frameworks and support pathologist consensus.
3

Regulatory guidelines emphasize patient safety and the need for validation strategies in AI applications for histopathology.
4

Transformer architectures and multimodal approaches are anticipated to further advance AI applications in histopathology.
5

Current AI systems for histopathology are non-autonomous and require human oversight, addressing ethical and regulatory concerns.

Frontiers In Digital Health

by Richard Oliver Matzko, Burak Kucukgoz, Pawel Gertner, Christopher Carey, Chris M. Bacon, Tong Xin
July 9, 2026

1