Skip to main content
Premium Trial:

Request an Annual Quote

Werfen Gets FDA Clearance for Thromboelastometry System

NEW YORK — Werfen said this week that it has received 510(k) clearance from the US Food and Drug Administration for its Rotem Sigma Thromboelastometry System for bleeding management.

The automated, cartridge-based, point-of-care system for patient blood management measures kinetic changes in the clot elasticity of whole-blood samples, enabling hemostasis optimization and minimizing blood loss.

"By viewing real-time, actionable results in the operating room, surgeons, anesthesiologists, and other clinicians can make faster and more informed transfusion decisions, improving patient outcomes and enhancing hospital efficiency," Remo Tazzi, VP of worldwide marketing and service, hemostasis, and acute care diagnostics at Werfen, said in a statement.

Werfen said it expects to launch the system in the US later this year.

In January, Barcelona, Spain-based Werfen received 510(k) clearance for a point-of-care hemostasis system.