Initial interactions with the FDA on developing a validation dataset as a medical device development tool.
PMID: 37794720 ·
Steven Hart, Victor Garcia, Sarah N Dudgeon, Matthew G Hanna, Xiaoxian Li, Kim Rm Blenman, Katherine Elfer, Amy Ly, Roberto Salgado, Joel Saltz, Rajarsi Gupta, Evangelos Hytopoulos, Denis Larsimont, Jochen Lennerz, Brandon D Gallas
Abstract
Quantifying tumor-infiltrating lymphocytes (TILs) in breast cancer tumors is a challenging task for pathologists. With the advent of whole slide imaging that digitizes glass slides, it is possible to apply computational models to quantify TILs for pathologists. Development of computational models requires significant time, expertise, consensus, and investment. To reduce this burden, we are preparing a dataset for developers to validate their models and a proposal to the Medical Device Developmen
Official Source
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