T2 Biosystems announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for the expanded T2Bacteria Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii, to the expansive panel. “We are thrilled to receive the FDA 510(k) clearance for the expanded T2Bacteria Panel, to include the detection of A. baumannii, as we believe it will lead to increased adoption of our proprietary direct-from-blood platform,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “The addition of A. baumannii represents the achievement of another successful product development and regulatory milestone for T2 Biosystems and increases the value proposition of the T2Bacteria Panel by covering approximately 75% of all sepsis-causing bacterial pathogens commonly found in blood stream infections.”
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