The FDA's April rejection of the industry deregulation proposal [1] does not represent a change in policy so much as a clarification of the one that existed all along. The agency has been approving AI medical devices on a rolling basis — the essential tremor wristband [4] being the most recent example — while consistently refusing to create class-level exemptions that would let software-driven clinical tools bypass individual review. What changed in April is that the refusal is now formal and documented, not implied by silence.