July 2024—Haemonetics Corp. has received FDA 510(k) clearance for the TEG 6s hemostasis analyzer system Global Hemostasis-HN assay cartridge. The cartridge extends the TEG 6s’ viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries and procedures and liver transplantation in laboratory and point-of-care settings.
The 510(k) clearance was supported by clinical data from a multicenter trial that included 335 patients undergoing cardiac bypass surgeries, interventional cardiology procedures, or liver transplantations. An additional study was conducted with 164 healthy volunteers to establish the normal reference ranges for the test cartridge. Overall, more than 5,500 clinical data points were used to demonstrate the safety and effectiveness of the Global Hemostasis-HN assays.
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