The FDA granted De Novo classification to HAI Solutions for its QIKCAP System, a UVC device designed to reduce microbes on needleless IV connectors. The decision establishes a novel regulatory pathway and a new predicate for similar point‑of‑care disinfection devices. De Novo clearance signals the agency’s willingness to evaluate novel device modalities for infection prevention. Hospitals and device manufacturers will watch how the QIKCAP entry affects device adoption, hospital protocols and procurement decisions tied to catheter‑associated infection risk reduction.