A U.S. district court decision overturned the FDA’s final rule to regulate laboratory‑developed tests (LDTs), marking a major regulatory defeat for the agency and crystallizing 2025 as a tumultuous year for diagnostic oversight. The court ruling, rendered in March 2025, has broad implications for diagnostics companies and laboratory operations. In Europe, the Medical Device Coordination Group posted guidance launching a pilot for breakthrough devices and diagnostics in mid‑2026, signaling regulators’ intent to create expedited pathways. The twin moves underscore divergent but active regulatory shifts across major markets in diagnostics and device policy.