HemoSonics announced today that it received FDA 510(k) clearance for its Quantra hemostasis system with the QStat cartridge.
FDA clearance expands the Quantra system’s indications to include trauma and liver transplantation procedures.
Durham, North Carolina-based HemoSonics designed the next-generation system to increase Quanta’s overall diagnostic capabilities. It covers the broadest range of indications of any point-of-care hemostasis analyzer in the U.S., according to a news release.
“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,” said Robert Roda, HemoSonics president and CEO. “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.”
About the Quantra platform
Quantra leverages SEER sonorheometry. The proprietary, medical-grade ultrasound technology helps to measure the coagulation properties of a whole blood sample.
The system enables clinicians to deliver patient-centered coagulation therapy. HemoSonics said it improves care and optimizes blood product usage. It also features rapid results, ease of operation and a dials screen for straightforward interpretation. The platform’s uses range across point-of-care settings including operating rooms, emergency departments and intensive care units.
HemoSonics offers the Quantra system with QPlus and QStat cartridges commercially in the U.S. It also offers the system in Europe, Australia, New Zealand, Japan and Hong Kong.
“Point-of-care data is the answer to PBM-guided patient decisions. It is a triple win; Patients get improved outcomes, public health is improved, and cost savings are achieved,” said Dr. Bruce Spiess, Medical Director of HemoSonics. “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 optimizing blood product usage and conserving critically low blood supplies.”