Fresenius Kabi Gets 510(k) Clearance for its Agilia Connect Infusion System

Fresenius Kabi has received 510(k) clearance from the FDA for its wireless Agilia Connect infusion system.

The system, which has been available outside the U.S. since 2016, includes a volumetric pump that can deliver continuous fluids at varying rates and a syringe pump for precise infusions.

The accompanying Vigilant software enables the warehousing of infusion data for reporting and analysis, and allows for wireless maintenance and calibration of the devices.

The patient infusion data that the system compiles can be configured on demand into reports for healthcare providers, the company said.