US-based medical device firm HemoSonics has received 510(k) market clearance for its Quantra Hemostasis System with QStat Cartridge from the US Food and Drug Administration (FDA).
This regulatory approval expands the indications of the Quantra system to include trauma and liver transplantation procedures.
The company stated that the QStat Cartridge assay increases Quantra’s overall diagnostic capabilities.
Now, the new next-generation whole blood hemostasis system covers the broadest range of clinical indications of any point-of-care hemostasis analyser in the US to date.
HemoSonics president and CEO Robert Roda said: “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.
“Today’s clearance significantly expands the clinical indications of the Quantra System, creating the greatest opportunity to address the critical unmet clinical needs of our healthcare provider partners and the patients that we serve.”
The Quantra System uses SEER sonorheometry to measure the coagulation properties of a whole blood sample.
It allows physicians to provide patient-centred coagulation therapy, which helps improve care and optimise the use of blood products.
HemoSonics stated that the system provides quick results and easy operation, along with a dials screen for straightforward interpretation.
It has received approval for use in point-of-care settings such as emergency departments, intensive care units and operating rooms.
HemoSonics medical director Dr Bruce Spiess said: “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.
“It has the potential to positively impact patient outcomes for hundreds of thousands of trauma patients and thousands of liver transplant recipients each year by optimising blood product usage and conserving critically low blood supplies.”