HemoSonics, LLC, a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced 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. 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,” said Robert Roda, President, and Chief Executive Officer of HemoSonics.
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The FDA clearance of the QStat Cartridge expands the Quantra System’s indications for use to include trauma, and liver transplantation procedures. The QStat Cartridge assay, in addition to the System’s already established QPlus® Cartridge assay, increases Quantra’s overall diagnostic capabilities to now cover the broadest range of clinical indications of any point-of-care hemostasis analyzer available in the U.S. market today.
“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.”
The Quantra System leverages innovative SEER Sonorheometry, a proprietary medical-grade ultrasound technology, to measure the coagulation properties of a whole blood sample. The System enables clinicians to deliver patient-centered coagulation therapy that improves care and optimizes blood product usage. With its rapid results, ease of operation, and dials screen for straightforward interpretation, the Quantra System is the only whole blood hemostasis testing system specifically cleared for use in point-of-care settings, such as operating rooms, emergency departments, and intensive care units.
SOURCE: PR Newswire