Fresenius Kabi has secured 510(k) regulatory approval from the US Food and Drug Administration (FDA) for its wireless Agilia Connect Infusion System.
This system includes the Agilia Volumetric Pump and the Agilia Syringe Pump with Vigilant Software Suite-Vigilant Master Med technology.
The company claimed that Agilia Connect volumetric pump and syringe pump are the first to be approved by adhering to TIR101 standards, which were developed by the Association for the Advancement of Medical Instrumentation (AAMI) last year.
Since 2016, the wireless Agilia Connect Infusion System has been available outside the US.
Building on the company’s first-generation Agilia Infusion System, the Agilia Connect Infusion System is available in over 130 countries with more than 1.2 million customer installations, offering wireless connectivity through the Vigilant Software Suite.
This software suite consists of Vigilant Master Med drug library software, Vigilant Insight infusion analytics software and Agilia Partner calibration and maintenance software.
The product offering allows the centralised distribution of drug libraries, warehousing of infusion data for reporting and evaluation, and wireless maintenance and calibration of devices.
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 features customised Master Drug Libraries that is based on every hospital or clinic’s approved medication protocols.
These drug libraries can be wirelessly, safely and securely distributed to a complete fleet of Agilia Connect Pumps.
Infusion data can be configured on demand into reports with the help of Vigilant Insight Continuous Quality Improvement software. This allows providers to carry out independent performance analyses across several health care facilities to achieve their infusion practice and patient safety aims.
