HemoSonics Gets FDA Clearance For Blood Analyzer System
Durham-based medical device developer HemoSonics has received an OK from the U.S. Food and Drug Administration to use its blood analyzer system in trauma and liver transplantation procedures.
The company has been granted FDA 510 (k) market clearance for its Quantra Hemostasis System with QStat Cartridge to assist doctors in evaluating whole blood samples to determine how well blood is clotting. Quantra uses a proprietary ultrasound technology, SEER Sonorheometry, that provides results in just a few minutes to allow physicians to make more informed treatment decisions.
“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, the company’s president and CEO. “Today’s (FDA) 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 we serve.”
HemoSonics said its Quantra Hemostasis System (QSat and QPlus cartridges) now covers the broadest range of clinical indications of any point-of-care hemostasis analyzer available in the United States.
“Point-of-care data is the answer to PBM (patient blood management)-guided patient decisions,” said Bruce Spiess, M.D., HemoSonics’ medical director. “It is a triple win: patients get improved outcomes, public health is improved, and cost savings are achieved.”
He noted that HemoSonics’ technology rapidly provides coagulation data that help doctors determine the blood constituents needed for individual transfusions. That information can drive better outcomes for thousands of trauma and liver transplant patients each year by improving blood product use and conserving critically low blood supplies.
HemoSonics said Quantra is the only whole blood hemostasis testing system specifically cleared for use in point-of-care settings that include intensive care units, operating rooms, and emergency departments. The system, with QPlus and QStat cartridges, is currently available in the U.S., Europe, Australia, New Zealand, Japan and Hong Kong.
HemoSonics, a University of Virginia spinout, was launched in 2010 and acquired by France’s Stago Group in 2017. The company has consolidated its worldwide headquarters and manufacturing operations in Durham’s MedTech Innovation Hub on Stirrup Creek Drive, but also maintains "a presence" in Charlottesville, Va. It declined to reveal its employment total.