FDA Programs and Business
- Entry #86
- 11 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 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://ncihub.org/groups/eedapstudies ). 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.