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Model Card for HistoGen

Model Description

HistoGen is an open-source computational pathology toolbox designed to support researchers and regulatory scientists in generating Histopathology cell nuclei images. The model source code and usage guidelines are available on the Histogen GitHub repository. For more information, please contact: seyed.kahaki@fda.hhs.gov.

Model Details

Model Type: Denoising Diffusion Probabilistic Model (DDPM)
Task: Segmentation-to-Image Synthesis
Domain: Histopathology/Medical Imaging
Code Repository: https://github.com/DIDSR/HistoGen/

Intended Use

This model is intended for research purposes in computational pathology, including:

Data augmentation for histopathology datasets
Synthetic image generation for model training

Installation and Usage

Only the model weights are hosted on Hugging Face. Source code along with full documentation and example notebook is available in the Github repository: HistoGen

Contact and Contributions

For any inquiries, suggestions, or collaborative opportunities, please contact Seyed Kahaki or Tahsin Rahman either via this GitHub repo or via email (seyed.kahaki@fda.hhs.gov or Tahsin.Rahman@fda.hhs.gov).

Disclaimer

About the Catalog of Regulatory Science Tools

The enclosed tool is part of the Catalog of Regulatory Science Tools, which provides a peer-reviewed resource for stakeholders to use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These tools do not replace FDA-recognized standards or MDDTs. This catalog collates a variety of regulatory science tools that the FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) developed. These tools use the most innovative science to support medical device development and patient access to safe and effective medical devices. If you are considering using a tool from this catalog in your marketing submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has not evaluated the suitability of these tools within any specific context of use. You may request feedback or meetings for medical device submissions as part of the Q-Submission Program. For more information about the Catalog of Regulatory Science Tools, email RST_CDRH@fda.hhs.gov.

Tool Reference

• Recommended Citation (will be revised when the tool is posted in the RST catalog):

U.S. Food and Drug Administration. (2026). HistoGen: A Generative AI tool for for Generating Nuclei Images (RSTXXXX.01). https://cdrh-rst.fda.gov/TBD

License

This model is released under the CC0-1.0 license

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