NEW YORK (360Dx) – Beckman Coulter said today that it has received Medical Device License approval from Health Canada for its DxH 900 Hematology Analyzer and its Early Sepsis Indicator.
The two tools were designed to improve a laboratory or institution's ability to detect "critical, potentially life-threatening, blood conditions, and/or diseases like sepsis," Beckman Coulter, which is part of Danaher, said in a statement.
The DxH 900 Hematology Analyzer was designed for mid- to high-volume clinical labs and has demonstrated 93 percent first-pass throughput, the firm said, adding it provides accurate flagging and reduces the number of slide reviews.
Meanwhile, the Early Sepsis Indicatior uses DxH 900's technology to offer near-native state cellular characterization for the early detection of sepsis. The solution is reported with routine blood testing typically run during an emergency department admission and allows clinicians to assess whether adult patients may be developing sepsis in acute care settings in less than one hour.
In June, Brea, California-based Beckman Coulter said it had filed a 510(k) application with the US Food and Drug Administration for clearance of the Early Sepsis Indicator, which is CE marked.