How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 2

Diagnostic Imaging January 20, 2025
Jeff Hall

In the second part of a two-part interview, Nina Kottler, M.D., says the transparency emphasis of the recent FDA guidance on AI-enabled software is welcome but needs to go beyond additional documentation to clarify how adjunctive AI is making its decisions.

Increased transparency is a cornerstone of the recent draft guidance from the Food and Drug Administration (FDA) on submissions for AI-enabled software. While this will result in an increased amount of documentation on the training as well as limitations for adjunctive use of AI models, Nina Kottler, M.D., maintained in a recent interview that this well-intended effort at transparency may fall short of having an impact in daily practice.

“ … Any of this documentation that the FDA is...

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