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March 15, 2022

FDA grants 510(k) clearance for Fresenius Kabi’s wireless Agilia System

The wireless Agilia Connect Infusion System includes the Agilia volumetric pump and Agilia syringe pump.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Fresenius Kabi’s wireless Agilia Connect Infusion System with Vigilant Software Suite-Vigilant Master Med Technology.

The wirelessly connected infusion pump system includes the Agilia volumetric pump and Agilia syringe pump.

The two pumps are claimed to be the first that have been cleared by FDA following the Association for the Advancement of Medical Instrumentation-developed TIR101 standards.

The company has been offering the wireless Agilia Connect infusion system outside the US since 2016. It has been installed by more than 126,000 customers.

The new wirelessly connected infusion pump system enables the centralised distribution of drug libraries, wireless maintenance and calibration of devices, and the warehousing of infusion data for reporting and analysis.

It has been developed based on the company’s first-generation Agilia infusion system and provides wireless connectivity through the Vigilant software suite.

The suite includes Vigilant Insight infusion analytics software, Vigilant Master Med drug library software, and Agilia Partner calibration and maintenance software.

Fresenius Kabi USA president and CEO John Ducker said: “Both patients and caregivers benefit from smarter devices that make health care safer and easier.

“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 US.”

Agilia includes customised Master Drug Libraries, which can be safely and securely distributed wirelessly to a fleet of Agilia Connect Pumps.

In 2020, Fresenius Kabi introduced its Glucagon Emergency Kit in the US for the treatment of severe hypoglycemic episodes in people with diabetes.

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