A federal court struck down the FDA’s final rule to regulate lab‑developed tests (LDTs), marking a major judicial rebuke of agency rulemaking and reshaping the diagnostics regulatory landscape for 2025. The ruling came amid broader policy moves: HHS proposed a new rule that would roll back several Biden‑era policies, eliminate many health‑tech certification criteria, and drop planned AI transparency requirements, arguing the changes reduce developer burden. The twin developments create immediate uncertainty for diagnostics, health‑tech vendors and AI toolmakers.