144: Court Halts FDA Rule on Lab-Developed Tests: What It Means for Pathology

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 rul...