The FDA's attempt to regulate laboratory developed tests as medical devices is over — for now. A federal court vacated the 2024 final rule, the agency declined to appeal, and the five-stage compliance clock was stopped. In this episode, Dr. Michael Laposata takes us inside the legal battle, explains why the court's March 2025 ruling matters far beyond LDTs, and makes the case for what real oversight reform should look like. From the limits of CLIA to the future of AI-driven diagnostics, Dr. Laposata — a world-renowned pathologist, educator, and author  — offers an authoritative and deeply personal perspective on one of the most consequential moments in the history of clinical laboratory medicine.