= This is a draft announcement = Summer is over, the new fiscal year is started (for the US gov), and we are planning our next year of research (at the FDA and hopefully in collaboration with members of the WSI WG community). * Brandon Gallas will give a !WebEx reprise of his presentation given at the European Congress of Pathology on 9 September 2018 * “Evaluating Computational Pathology at the US FDA and Related Research.” ([https://nciphub.org/groups/wsi_working_group/wiki/Presentation:Gallas2018_ECP link to presentation]) * !WebEx Date and Time: Thursday at 11am on 11 October 2018 (LinkToWebExInfo) * In addition to the ECP presentation, we plan to summarize research plans for the coming year: * Collecting data (images and annotations) to be qualified by the FDA as Medical Device Development Tools (MDDTs) to be used in submissions to the FDA to validate algorithms (LinkToPlainLanguageSummary) * One sentence description of proposal related to TPA WSI (LinkToPlainLanguageSummary) * One sentence description of proposal related to TPA algorithms (LinkToPlainLanguageSummary) * Brandon Gallas is conducting a pilot reader study at the Annual Meeting of the American Society of Clinical Pathologists in Baltimore on 3-5 October 2018. * This pilot is to support the data MDDT project mentioned above. * The pathologists’ tasks are to evaluate lymphocytes in lung tumors. * Come find the booth, hear about the study, and participate! * We hope to follow up the pilot with pivotal study at the San Antonio Breast Cancer Symposium or other venue with many pathologists. If you are a conference organizer or are leadership in a professional society and want to help make this happen, please contact Brandon. * Check out, “[https://www.frontiersin.org/articles/10.3389/fmed.2018.00241/full Advancing Regulatory Science with Computational Modeling for Medical Devices at the FDA’s Office of Science and Engineering Laboratories]”. You will be surprised by what is happening at the FDA. * Enough of Brandon and the FDA, it’s time to hear from the WSI WG. What are you doing? What are your concerns? What discussions and collaborations should we be having? Several WSI WG members have asked what happened to the discussions about using phantoms for the technical performance assessment of WSI scanners, especially as image quality impacts training and testing in computational pathology. How should we leverage and engage the 145 WSI WG members? Please send Marios Gavrielides ideas (Marios.Gavrielides@fda.hhs.gov).