Q-linea ASTar System receives US FDA 510(k) clearance
ASTar enables rapid therapeutic response to sepsis directly from a positive blood culture
9 May 2024
Q-linea has announced that the US Food and Drug Administration (FDA) has granted 510(k) market clearance for the company’s ASTar® System, enabling market launch to hospitals and laboratories in the United States.
According to the Centers for Disease Control and Prevention, at least 1.7 million adults in the United States develop sepsis each year and nearly 270,000 die as a result. ASTar enables rapid therapeutic response to sepsis directly from a positive blood culture in approximately six hours, giving physicians the tool needed to improve patient outcomes and reduce mortality.
Stuart Gander, CEO of Q-linea, says, “The approval is a significant step for Q-linea in the infectious disease diagnostics field in the U.S. Feedback from hospitals that have had early access to ASTar has been very positive, and we are excited to now be able to bring the system to labs across the US, which will make a real difference for patients with severe blood stream infections. We are pleased with the panel of drug-bug combinations which has been approved.”