HEMOSONICS AWARDED FDA 510(k) CLEARANCE FOR QUANTRA® HEMOSTASIS SYSTEM WITH QSTAT® CARTRIDGE
DURHAM, N.C., Nov. 30, 2022 /PRNewswire/ -- HemoSonics, LLC, a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced today that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge.
- "The Quantra Hemostasis System with QStat Cartridge is breaking new ground and leading innovation in the point-of-care and laboratory-based whole blood hemostasis testing market.
- The FDA clearance of the QStat Cartridge expands the Quantra System's indications for use to include trauma, and liver transplantation procedures.
- "The Quantra Hemostasis System with QStat and QPlus Cartridges will assist more clinicians in determining which specific blood products are needed to rapidly treat individual patients.
- HemoSonics is part of the Stago group, a leading company in thein vitrodiagnostics industry dedicated to exploring thrombosis and hemostasis.