Q-linea AB announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance for the company's ASTarSystem, 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.
