Specialised diagnostics firm Werfen has received the US Food and Drug Administration (FDA) 510(K) clearance for its ROTEM sigma Thromboelastometry System.

The ROTEM sigma provides real-time, quick, and actionable findings to direct bleeding management right at the point of care (POC).

Werfen said the system will be sold in the US later this year after being used in clinical settings in Europe, Australia, Asia, Latin America, and Africa.

The ROTEM sigma Thromboelastometry System, which is based on tried-and-true cup-and-pin technology, uses assays similar to those of its predecessor, the ROTEM delta Thromboelastometry System.

It also offers a quick assessment of clot hardness and stability for a clear image of coagulopathy, enabling hemostasis optimisation and reducing blood loss.

The end result is a decrease in unnecessary transfusions, related complications, and expenditures, all of which are crucial for the patient blood management (PBM) programme to be effective.

According to the firm, ROTEM sigma is perfect for POC testing since it is cartridge-based, completely automated, and easy to use.

It shows enlarged viscoelastic testing data, and simple-to-read TEMograms for better and quick interpretation.

The ROTEM sigma supports focused therapy decisions in a range of clinical situations due to its extensive test menu and four independent channels.

Also, the ROTEM sigma complete + hep cartridge provides intraoperative outcomes in cardiovascular surgery and liver transplantation for crucial operations, including those needing heparin neutralisation.

The firm said that ROTEM sigma has ready-to-use, room-temperature cartridges with integrated closed-tube sampling simplify testing in order to save time and standardise the testing process.

Werfen Hemostasis and Acute Care Diagnostics Worldwide Marketing and Service VP Remo Tazzi said: “Reducing inappropriate transfusions is paramount in healthcare today for patient safety, to help preserve blood supply, and for cost containment.

“Incorporating ROTEM sigma testing into a PBM program allows hospitals to achieve these goals.

“By viewing real-time, actionable results in the operating room, surgeons, anesthesiologists, and other clinicians can make faster and more informed transfusion decisions, improving patient outcomes and enhancing hospital efficiency.”