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Podcast: Digital Pathology Podcast
Episode: 144: Court Halts FDA Rule on Lab-Developed Tests: What It Means for Pathology
Description: Send us Fan MailWill 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 medicineWhy the FDA rule sparked backlash from the pathology community