Werfen Received 510(k) Clearance for Bleeding Management Device

The FDA granted Barcelona, Spain-based Werfen a 510(k) clearance for its ROTEM sigma blood coagulation test for patients who need bleeding management.

The cartridge-based system, which delivers rapid results at the point of care within 15 minutes, helps clinicians to avoid inappropriate transfusions. It also allows them to optimize hemostasis while minimizing blood loss and blood product exposure.

The device allows surgeons, anesthesiologists, and other clinicians to “make faster and more informed transfusion decisions, improving patient outcomes and enhancing hospital efficiency,” the company said.  

Werfen plans to launch the Rotem sigma system in the U.S. later this year.