Fresenius Kabi receives regulatory clearance from the FDA for infusion pump system

Fresenius Kabi announced today that it has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for its wireless Agilia® Connect Infusion System which includes the Agilia Volumetric Pump and the Agilia Syringe Pump with Vigilant® Software Suite-Vigilant Master Med technology. Both pumps are the first to be cleared by following TIR101 standards, which were developed by the Association for the Advancement of Medical Instrumentation (AAMI) in 2021. The product offering for hospitals and clinics enables the centralized distribution of drug libraries, warehousing of infusion data for reporting and analysis, and wireless maintenance and calibration of devices. The clearance is an important milestone for the company’s infusion therapy business in the U.S.