FDA Greenlights First Human Trial for ConformalFLASH Proton Therapy

The FDA has granted an Investigational Device Exemption for IBA's ConformalFLASH proton therapy, paving the way for its initial human clinical study in the United States. This pilot study, C-FLASH-01, is set to begin in summer 2026 at the University of Pennsylvania. It will enroll ten patients requiring re-irradiation for head and neck cancers, exploring a new approach to radiation treatment.