Fresenius Kabi announced today that it received FDA 510(k) clearance for its wireless Agilia Connect infusion system.
Lake Zurich, Illinois-based Fresenius Kabi’s Agilia Connect infusion system includes the Agilia volumetric pump and the Agilia syringe pump with Vigilant software suite-Vigilant Master Med technology.
According to a news release, the two pumps are the first to be cleared by following TIR101 standards. The Association for the Advancement of Medical Instrumentation (AAMI) developed the standareds in 2021.
Fresenius Kabi has offered the wireless Agilia Connect infusion system outside the U.S. since 2016. It’s built on its first-generation Agilia infusion system to provide wireless connectivity through the Vigilant software suite, which includes the Vigilant Master Med drug library software, Vigilant Insight infusion analytics software and Agilia Partner calibration and maintenance software.
The company said the entire offering enables the centralized distribution of drug libraries, warehousing of infusion data for reporting and analysis and wireless maintenance and calibration of devices. The drug libraries can be safely and securely distributed wirelessly to a fleet of Agilia Connect pumps, and infusion data can be configured on-demand into reports.
“Both patients and caregivers benefit from smarter devices that make health care safer and easier,” Fresenius Kabi USA President and CEO John Ducker said in the release. “As a company with more than 35 years of global infusion technology expertise, we look forward to establishing Fresenius Kabi as the partner of choice for infusion therapy in the U.S.”