Q-Linea
Q-linea installs first ASTars in the United States pending market approval
Q-linea AB (publ) (OMX:QLINEA) today announces that the company has installed its first two systems in the United States, offering selected sites access to ASTar, pending marketing authorization and commercial launch.
“We see that we are nearing marketing approval and commercial launch. As part of the launch preparations, we are now installing two systems giving potential customers the opportunity to get to know the system better. The systems are installed at two very reputable sites, which we hope will be some of the first to order the system once it is commercially available”, said Jonas Jarvius, CEO of Q-linea.
“We are excited to begin the next phase of our journey of introducing Q-linea and ASTar in the US. Interest by prominent laboratory and clinical thought leaders across the US has been strong for evaluating the potential impacts of rapid AST in their healthcare systems. As we prepare for commercial launch, we are excited to gain further insights into the potential impacts our rapid AST solution can have on sepsis and patient management”, said Jim Kathrein, VP of Commercial Operations for Q-linea Inc.
The systems are installed for research use only (RUO).
About ASTar Instruments and ASTar BC G-Kit
ASTar Instrument and ASTar BC G-Kit already deliver the broadest answer regarding the combination of the number of antibiotics and the number of double dilution steps of each antibiotic, in a single analysis for gram-negative bacteria. The test enables the analysis of gram-negative bacteria, including difficult-to-grow so-called fastidious bacteria, which satisfies the need for rapid and comprehensive results to support optimal treatment decisions.
ASTar Instrument and ASTar BC G- Kit are CE-marked but not FDA 510(k)-cleared and not available for sale in the United States.
Datum | 2023-12-28, kl 11:50 |
Källa | MFN |