Episode
LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach
- Podcast
- Let's Talk Risk! Podcast
- Published
- Mar 20, 2026
- Duration seconds
- 1742
- Processing state
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Summary
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 human factor: vigilance and better questions 18:10 FDA and CDx: what “evolving approach” may signal 21:30 Dataset boundaries, bias, and representativeness as safety issues 25:40 Closing: adapting to rapid AI rise through discipline + alignment If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter . Suggested links: LTR: Three Pillars for Defining Your IVD Risk Management Strategy . LTR: Responsible AI and Future of MedTech Safety . FDA: Companion Diagnostics . Key Takeaways * CDx is high-stakes by design. If the test can steer therapy, FDA (and clinicians) will d…