Werfen’s Whole Blood Hemostasis Test Cleared
Bedford, Mass.-based Werfen has received the FDA’s 510(k) clearance for its Gem Hemochron 100 whole-blood hemostasis system.
The cartridge-based diagnostic test, which measures the patient’s blood-clotting time, is used to optimize heparin dosing and to help in making patient management decisions.
The device is currently in clinical use in several European countries. Werfen said it will begin marketing it in the U.S. early this year.