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.
Brandon D. Gallas @ on
"The Gray Sheet"
Companies, Hospitals Line Up As FDA Device Center Training Sites
By David Filmore / Email the Author / View Full Issue
Regulatory & Policy News / Word Count: 578 / Article # 01150518005 / Posted: May 14 2015 4:40 PM
Companies, Hospitals Line Up As FDA Device Center Training Sites More than 30 medical device-makers and clinical sites extended onsite invites to CDRH staffers to learn more about a wide array of industry topics, including neurointerventional device issues, male condom manufacturing, product reprocessing and sterilization methods.
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Brandon D. Gallas @ on
Docket for: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Guidance for Industry and Food and Drug Administration Staff
http://www.regulations.gov/#!docketDetail;D=FDA-2015-D-0230
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