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Content provided by Aleksandra Zuraw, DVM, PhD, Aleksandra Zuraw, and DVM. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Aleksandra Zuraw, DVM, PhD, Aleksandra Zuraw, and DVM or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
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144: Court Halts FDA Rule on Lab-Developed Tests: What It Means for Pathology

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Manage episode 498629130 series 3404634
Content provided by Aleksandra Zuraw, DVM, PhD, Aleksandra Zuraw, and DVM. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Aleksandra Zuraw, DVM, PhD, Aleksandra Zuraw, and DVM or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

Send us a text

Will FDA rules disrupt the way we diagnose diseases?

In this episode, I break down a seismic shift in lab medicine: a federal court has vacated the FDA’s controversial rule classifying lab-developed tests (LDTs) as medical devices. This change carries serious implications for innovation, digital pathology, AI-based diagnostics, and small labs across the U.S.

🎧 What You’ll Hear:

  • What LDTs are and why they matter for rare diseases and personalized medicine
  • Why the FDA rule sparked backlash from the pathology community
  • What the court’s decision means for AI algorithms in digital pathology
  • What’s next: Will Congress revive the VALID Act?
  • How this affects labs, startups, and the future of diagnostic innovation

This podcast is packed with updates every pathology professional should know. 🔍

Support the show

Become a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!

  continue reading

151 episodes

Artwork
iconShare
 
Manage episode 498629130 series 3404634
Content provided by Aleksandra Zuraw, DVM, PhD, Aleksandra Zuraw, and DVM. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Aleksandra Zuraw, DVM, PhD, Aleksandra Zuraw, and DVM or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

Send us a text

Will FDA rules disrupt the way we diagnose diseases?

In this episode, I break down a seismic shift in lab medicine: a federal court has vacated the FDA’s controversial rule classifying lab-developed tests (LDTs) as medical devices. This change carries serious implications for innovation, digital pathology, AI-based diagnostics, and small labs across the U.S.

🎧 What You’ll Hear:

  • What LDTs are and why they matter for rare diseases and personalized medicine
  • Why the FDA rule sparked backlash from the pathology community
  • What the court’s decision means for AI algorithms in digital pathology
  • What’s next: Will Congress revive the VALID Act?
  • How this affects labs, startups, and the future of diagnostic innovation

This podcast is packed with updates every pathology professional should know. 🔍

Support the show

Become a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!

  continue reading

151 episodes

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