Haemonetics Gets 510 (K) Clearance For TEG 6s Hemostasis - HN Cartridge

(RTTNews) - Haemonetics Corp. (HAE) on Thursday announced that it has received 510(k) clearance from the FDA for the new TEG 6s Hemostasis analyzer system Global Hemostasis-HN assay cartridge.

This new cartridge expands Haemonetics' TEG 6s viscoelastic testing capabilities to cater to fully heparinized patients in adult cardiovascular surgeries, procedures, and liver transplants in both lab and point-of-care settings.

The cartridge offers clinicians comprehensive insights into a patient's coagulation profile, providing faster and more detailed information for actionable results compared to traditional coagulation tests.

The FDA clearance was based on clinical data from a multi-center trial involving 335 patients undergoing cardiac bypass surgeries, interventional cardiology procedures, or liver transplants.