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HemoSonics Bleeding Management System Nabs Expanded FDA 510(k) Clearance

NEW YORK – Bleeding management company HemoSonics announced Wednesday that it has received special 510(k) clearance from the US Food and Drug Administration for the expanded use of arterial blood samples with its Quantra QStat cartridge. 

The QStat cartridge, which is used with the firm's Quantra Hemostasis Analyzer, first received 510(k) clearance in 2022 for use with venous whole-blood samples. The Quantra Hemostasis System includes the analyzer and QPlus and QStat cartridges and is FDA-cleared for use in point-of-care settings like operating rooms and intensive care units as well as in hospital laboratories, the Durham, North Carolina-based company said in a statement. 

The analyzer provides comprehensive blood analysis for critical bleeding disorders and is intended to help clinicians manage patients back into hemostasis, the firm added. 

The new clearance "will make it easier and more convenient for hospitals to use the Quantra System," HemoSonics President and CEO Bob Roda said in a statement. "The Quantra System now has the broadest range of FDA-cleared clinical indications of any cartridge-based viscoelastic testing system." 

The system is cleared for use in cardiac, trauma, liver, and major orthopedic surgeries, he noted. It provides comprehensive whole-blood coagulation analysis typically in less than 15 minutes.