FDA Programs and Business
- Entry #86
- 9 comments
This blog contains information about FDA programs and ways to interact with FDA scientists and regulatory staff.
About the author
Brandon D. Gallas provides mathematical, statistical, and modeling expertise to the evaluation of medical imaging devices at the FDA. His main areas of research are in the design and statistical analysis of reader studies (https://github.com/DIDSR/iMRMC/releases), image quality, computer-aided diagnosis, and imaging physics. He began working on whole slide imaging devices as part of his regulatory responsibilities at the FDA in 2009. He turned his research effort in this direction and has been investigating the design, execution, and analysis of feature studies to compare pathologist performance and reproducibility using whole slide imaging devices and using the microscope. These studies are enabled by eeDAP, an evaluation environment that registers the digital images to the glass slides (https://github.com/DIDSR/eeDAP/releases ). Dr. Gallas is also an organizer of a working group focused on the evaluation of whole slide imaging technical and pathologist performance (https://nciphub.org/groups/wsi_working_group ).