May 3, 2019–HemoSonics announced that its Quantra Hemostasis Analyzer platform and QPlus cartridge have been granted de novo marketing authorization by the FDA and are available for sale in the United States.
The Quantra enables clinicians to assess coagulation status of perioperative patients at the point of care. The system uses a sealed consumable cartridge to run a panel of viscoelastic blood coagulation tests. Hands-on time is less than one minute and results are provided in 15 minutes or less.
“The Quantra Hemostasis Analyzer is revolutionary and a dramatic improvement over existing tools,” Danja Groves, MD, PhD, an anesthesiologist in Charlottesville, Va., said in a press release from HemoSonics. “Using the Quantra, clinicians have information that was previously unavailable in a time frame that enables proactive bleeding management. This is a game-changer for transfusion management.”
The company’s patented SEER sonorheometry ultrasound technology provides fully automated testing in a closed system. It also introduces unique parameters, the company says, which assess platelet contribution to clot stiffness and the likelihood of residual heparin in the sample.