Regulatory Approvals

United States: The U.S. FDA approved the EMPAVELI Injector combination product, based on enFuse technology, for at-home self-administration with a specific drug.

European Union: The enFuse on-body injector (OBI) and syringe transfer (ST) system received European Union Medical Device Regulation (EU MDR) CE Mark approval for HCP use in-clinic.

United Kingdom: The enFuse on-body injector (OBI) and syringe transfer (ST) system has been registered with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) for HCP use in-clinic.

Brazil:  The enFuse System (syringe and vial transfer) received approval from the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ANVISA) for HCP and layperson use in-clinic or at-home.