| | --- |
| | language: |
| | - en |
| | license: mit |
| | tags: |
| | - diffusion |
| | - image-generation |
| | - histopathology |
| | - medical-imaging |
| | - segmentation-to-image |
| | datasets: |
| | - MoNuSeg |
| | - TNBC |
| | - data_science_bowl_2018 |
| | - PanNuke |
| | metrics: |
| | - fid |
| | library_name: nudiff |
| | pipeline_tag: image-to-image |
| | --- |
| | |
| | # 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](https://github.com/DIDSR/HistoGen/). For more information, please contact: [seyed.kahaki@fda.hhs.gov](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](https://github.com/DIDSR/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](https://cdrh-rst.fda.gov/), 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](https://www.fda.gov/medical-devices/medical-device-development-tools-mddt) 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](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program) as part of the Q-Submission Program. |
| | For more information about the Catalog of Regulatory Science Tools, email [RST_CDRH@fda.hhs.gov](mailto:RST_CDRH@fda.hhs.gov). |
| |
|
| | ## Tool Reference |
| | <!-- • RST Reference Number: RSTXXXX.01 --> |
| |
|
| | <!-- • Date of Publication: XX/XX/XXXX --> |
| |
|
| | • 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 |
| |
|
