Medical technology solutions company Haemonetics Corporation (NYSE:HAE) announced on Thursday that it has obtained US Food and Drug Administration (FDA) 510(k) clearance for its TEG 6s hemostasis analyzer system Global Hemostasis-HN assay cartridge.

This expansion enhances TEG 6s testing capabilities for fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation settings, across laboratories and point-of-care. Rapid assessment of a patient's hemostasis status is crucial for optimal clinical outcomes and blood product management.

Haemonetics' cartridge-based TEG 6s system offers comprehensive coagulation profiles swiftly, surpassing conventional tests with actionable results. Supported by TEG Manager software, the TEG 6s analyzer provides real-time results viewing and customizable alert messages for interpretation guidance.

The release of the new Global Hemostasis-HN cartridge for TEG 6s system is scheduled in the upcoming months, following successful 510(k) clearance backed by extensive clinical trials involving 335 patients and establishment of normal reference ranges using 164 healthy volunteers, totaling over 5,500 clinical data points.