GEM Hemochron 100 Whole Blood Hemostasis Testing System Cleared by FDA

Werfen announced that the GEM Hemochron 100 whole blood hemostasis system received 510(k) clearance by the US Food and Drug Administration (FDA). Currently in clinical use in some European countries, the GEM Hemochron 100 system will be commercialized in the US early this year.

Activated clotting time (ACT) results can be delivered in minutes with this system, which allows better patient-management decisions and improves workflow at the point of care (POC).

The GEM Hemochron 100 system optimizes heparin dosing and enables rapid initiation of critical procedures for enhanced patient management. The time and complexity of testing is reduced by the cartridge-based technology, in addition to the need for training and maintenance.

The system maintains an intuitive user interface along with other features, like a large touch screen, that make it much more accessible, allowing efficient utilization.

"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," Remo Tazzi, VP, Worldwide Marketing and Service, Hemostasis and Acute Care Diagnostics, at Werfen said in a statement. "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."

Hemochron technology was first introduced in 1983, displaying a long history of success in point of care testing. Throughout each generation of Hemochron systems efficiency has continued to improve.

The GEM Hemochron 100 offers the highest level of speed, simplicity, and connectivity in whole blood hemostasis testing, the Werfen press release stated.

The design is aimed for invasive procedures requiring heparin dose adjustment, in cases where ACT results are essential. These results are attained rapidly and accurately with this system.

Testing flexibility is possible in a variety of settings, utilizing 2 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.

Whether it’s the Cardiovascular Operating Room (CVOR), Intensive Care Unit (ICU), Cardiac Catheterization or Electrophysiology Lab, the GEM Hemochron 100 can facilitate optimal workflow and better outcomes with its speed and efficiency.