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Werfen POC Hemostasis System Obtains FDA 510(k) Clearance

NEW YORK – Werfen announced on Tuesday that its GEM Hemochron 100 whole blood hemostasis system has received 510(k) clearance from the US Food and Drug Administration.

The point-of-care platform delivers activated clotting time, or ACT, results in minutes and is intended to help improve workflow and patient management decisions, Werfen said in a statement. It is currently in clinical use in several European countries and will be commercialized in the US in early 2022, the Barcelona, Spain-based company added.

By delivering ACT results more quickly than traditional systems, Werfen's system can help optimize heparin dosing and enable rapid initiation of critical procedures, the firm said. The platform uses cartridge-based technology to reduce the time and complexity of testing and make it easier to use.

It is designed for invasive procedures that require heparin dose adjustment, including those in the cardiovascular operating room, the cardiac catheterization laboratory, intensive care units, and the electrophysiology lab, the company said.

Two ACT tests are available: ACT+ for moderate-high heparin doses and ACT-LR for low-moderate doses. The assays provide a maximally activated clotting time, which Werfen said enables a shorter testing time, reduces susceptibility to hypothermia and artifacts, removes variability induced by hemodilution, and correlates more closely to factor Xa activity, which indicates the activity of heparins.

"In critical procedures, such as cardiac surgery, accuracy, speed, and reliability of whole blood hemostasis testing to guide heparin therapy is paramount," Remo Tazzi, Werfen's VP of worldwide marketing and service for hemostasis and acute care diagnostics, said in a statement. The GEM Hemochron 100 "allows clinicians to make informed patient management decisions at the point of care, helping improve patient outcomes in the cardiovascular operating room and other acute care settings."