A federal district court vacated the FDA’s final rule on regulation of laboratory‑developed tests (LDTs), delivering what commentators called the regulatory story of 2025. The court decision followed legal challenges and has halted the agency’s bid to more tightly regulate in‑house clinical tests. The ruling reshapes the diagnostics regulatory landscape and may slow FDA attempts to expand oversight of clinical labs, including future AI‑driven diagnostics. Stakeholders—clinical labs, device makers and payers—will reassess compliance plans and advocacy strategies as legal and policy actors consider next steps.