Werfen says its GEM Hemochron 100 Whole Blood Hemostasis system received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The GEM Hemochron 100 system is designed to deliver fast, actionable activated clotting time (ACT) results in minutes, informing patient-management decisions, and helping improve workflow at the point of care (POC). The system is currently in clinical use in several European countries and will be commercialized in the U.S. in early 2022.

The GEM Hemochron 100 system optimizes heparin dosing and enables rapid initiation of critical procedures for enhanced patient management.

“In critical procedures, such as cardiac surgery, accuracy, speed and reliability of whole blood hemostasis testing to guide heparin therapy is paramount—and the GEM Hemochron 100 delivers,” says Remo Tazzi, VP, Worldwide Marketing and Service, Hemostasis and Acute Care Diagnostics, at Werfen. “This 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.” 

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 and ACT-LR for low-moderate 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. 

Supporting current clinical practice guidelines, GEM Hemochron 100 ACT tests provide a maximally activated clotting time. This enables a shorter testing time, reduces susceptibility to hypothermia and artifacts, removes variability induced by hemodilution and correlates more closely to factor Xa activity, when compared to tests using a single activator.

New integrated Wi-Fi capabilities in the GEM Hemochron 100 enable wireless, automatic, bidirectional data transmission and remote configuration. The GEM Hemochron 100 also offers an encrypted connection to ensure the security of patient data.