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144: Court Halts FDA Rule on Lab-Developed Tests: What It Means for Pathology
Manage episode 498629130 series 3404634
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. 🔍
Become a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!
151 episodes
Manage episode 498629130 series 3404634
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. 🔍
Become a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!
151 episodes
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