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Profile

  • Organization
    FDA/CDRH/OSEL, Division of Imaging, Diagnostics, and Software Reliability

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  • Biography
    Brandon D. Gallas provides mathematical, statistical, and modeling expertise to the evaluation of medical imaging devices at the FDA (https://www.fda.gov/medical-devices/medical-device-regulatory-science-research-programs-conducted-osel/digital-pathology-program-research-digital-pathology-medical-devices). His main areas of research are image quality, computer-aided diagnosis, imaging physics, and the design, execution, and statistical analysis of reader studies (https://github.com/DIDSR/iMRMC/releases, https://cran.r-project.org/web/packages/iMRMC/index.html). Recently, he has been investigating pathologist performance and agreement using whole slide imaging devices and the microscope (https://didsr.github.io/HTT.home/). These studies are enabled by an evaluation environment that registers the digital images to the glass slides (https://github.com/DIDSR/eeDAP/releases). Dr. Gallas also participates in the Pathology Innovation Collaborative Community (https://www.pathologyinnovationcc.org/), a regulatory science initiative to harmonize and standardize digital pathology processes to speed up innovation to patients.