LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach
From Let's Talk Risk! with Dr. Naveen Agarwal by Casual and informal conversations about practical aspects of medical device risk management.
March 20, 2026 · 29 min
About this episode
The episode discusses the impact of AI on companion diagnostics and the evolving expectations of the FDA.
Summary “Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.” Companion diagnostics (CDx) are inherently high-consequence because they can directly shape treatment decisions. That reality drives a higher bar for clarity: intended use boundaries, evidence expectations, and tight specificity in what the test is claiming and for whom. In this Let’s Talk Risk! conversation , host Naveen Agarwal sits down with Chris Daly to discuss how AI is transforming the MedTech landscape, including CDx, and how FDA’s expectations are evolving in this area. Chris emphasizes anchoring on the clinical question, using AI as a tool (not a vague strategy), and making uncertainty explicit: not “can we explain everything,” but “how much uncertainty is acceptable for this intended use?” Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 2026 context: uncertainty is rising; fundamentals matter 05:00 CDx basics: why CDx is different (and higher-stakes) 07:05 AI/ML + diagnostics: define the question, bound the tool 09:40 Explainability vs uncertainty: “how much confidence is enough?” 14:10 The…
People in this episode
Host: Naveen Agarwal
Guest: Chris Daly
Topics covered
- companion diagnostics
- AI in MedTech
- FDA regulations
- uncertainty in diagnostics
- clinical decision-making
Keywords
- companion diagnostics
- AI
- FDA
- uncertainty
- medical devices
- diagnostics
- clinical questions
Mentioned in this episode
Organizations: FDA
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