The FDA granted De Novo classification to HAI Solutions’ QIKCAP System, a UVC device designed to reduce microbial contamination on needleless IV connectors. The decision marks a regulatory milestone for ultraviolet disinfection devices in vascular access, potentially changing infection‑control practices in hospitals and outpatient infusion centers. HAI says the clearance recognizes the system as a novel, low‑risk alternative for connector decontamination.