MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – June 20, 2025
One Big Thing Regulation just removed the moat around radiology AI. On 13 June the FDA re‑classified radiological CADe/CADx from Class III (PMA) to Class II (510(k)). That turns a US $3‑5 M, 30‑month slog into a sub‑$500 k, 90‑day filing. Our model (see Visual 3) shows ≥1,000 additional filings through 2026, compressing prices for “me‑too” algos and transferring value to orchestration platforms and data owners. […]
