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Home > Digital Pathology Podcast > 144: Court Halts FDA Rule on Lab-Developed Tests: What It Means for Pathology
Podcast: Digital Pathology Podcast
Episode:

144: Court Halts FDA Rule on Lab-Developed Tests: What It Means for Pathology
Category: Science & Medicine
Duration: 00:09:48
Publish Date: 2025-08-06 12:00:00
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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.
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