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CE mark for Beckman’s Early Sepsis Indicator

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May 11, 2018Beckman Coulter announced its Early Sepsis Indicator received the CE mark. The Early Sepsis Indicator is a hematology-based solution designed to alert emergency department clinicians to the possibility of sepsis or risk of developing sepsis and offered as part of a routine CBC with differential test. The new marker will be commercially available on the recently launched DxH 900 hematology analyzer.

“Because emergency department personnel are often on the front line of care for people facing critical conditions, giving them a simple and easy tool for detecting sepsis can help us make significant strides against this prevailing threat,” Peter Soltani, PhD, SVP and general manager of the hematology business at Beckman Coulter, said in a press release. “The fact that this early warning indicator is part of a routine blood test means that clinicians receive results rapidly, with no additional workflow burden to the laboratory or emergency department.”

The Early Sepsis Indicator uses the DxH 900’s Coulter technology, which characterizes cells in their near-native states. The system’s VCS 360 technology can detect morphological changes in monocytes, cells of the innate immune system that provide a first line of defense against infections.

The company plans to submit a 510(k) to the FDA for the Early Sepsis Indicator in the near future.

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