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 in FDA’s Office of Science and Engineering Laboratories, and hopefully in collaboration with members of the WSI WG community. A reminder here is that OSEL is the research arm of CDRH and does not necessarily reflect any specific policy/decision making of CDRH’s regulatory offices (OIR or ODE).
- 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.” (Link to presentation.)
- WebEx Date and Time: Thursday at 11am on 11 October 2018 (Link to WebEx info.)
- Berkman Sahiner and Weijie Chen plan to expand the evaluation of artificial intelligence and machine learning devices to less structured post-market reference standards and higher risk/higher impact autonomous use.
- Marios Gavrielides plans to …
- 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 a 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.