FDA authorizes Werfen’s whole blood hemostasis test

Jan. 7, 2022

Werfen has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a cartridge-based test that measures a patient’s blood-clotting time.

The Gem Hemochron 100 whole-blood hemostasis system is used to optimize heparin dosing and to help in making patient management decisions.

Werfen said the device is currently in clinical use in several European countries will be marketed in the U.S. in early 2022.

Leveraging leading Hemochron technology, the GEM Hemochron 100 system delivers activated clotting time (ACT) results in minutes. Cartridge-based technology reduces time and complexity of testing, as well as the need for training and maintenance.

The GEM Hemochron 100 is designed for invasive procedures requiring heparin dose adjustment, where rapid and accurate ACT results are essential. Two ACT tests, ACT+ for moderate-high heparin doses (1–6 IU/mL) and ACT-LR for low-moderate (up to 2.5 IU/mL) heparin doses, offer testing flexibility in a variety of clinical settings, including the cardiovascular operating room (CVOR), cardiac catheterization lab, electrophysiology lab and intensive care units.

“In critical procedures, such as cardiac surgery, accuracy, speed and reliability of whole blood hemostasis testing to guide heparin therapy is paramount,” said Remo Tazzi, Vice President of Worldwide Marketing and Service, Hemostasis and Acute Care Diagnostics, at Werfen.

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