07Oct 2023
Initial interactions with the FDA on developing a validation dataset as a medical device development tool

Initial interactions with the FDA on developing a validation dataset as a medical device development tool

Pathologists face challenges quantifying tumor-infiltrating lymphocytes (TILs) in breast cancer. A solution emerges as a dataset proposal seeks FDA qualification for TIL density models. This effort aims to relieve developers by simplifying validation and enabling regulatory submissions within the use context. The initiative's detailed process, including early FDA interactions, sets a standard for stromal TIL density estimation and other computational models.

  • #oncology

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