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FDA grants de novo for the HemoSonics’ Quantra® QPlus® System; Now Commercially Available in US

Thursday, March 14, 2019  
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HemoSonics announced that its innovative Quantra Hemostasis Analyzer platform, and its initial QPlus cartridge have been granted de novo marketing authorization by the FDA and are now available for sale in the United States.

The fast and easy-to-use Quantra QPlus System provides novel and actionable information on coagulation status to clinicians at the point of care. With hands-on time of less than a minute, the Quantra QPlus System leverages innovative ultrasound technology to provide rapid viscoelastic results in 15 minutes or less, using a simple workflow and intuitive interface. When time is most critical, Quantra’s rapid, precise and easy to read results may allow clinicians to quickly make more informed decisions.

“The Quantra Hemostasis Analyzer is revolutionary and a dramatic improvement over existing tools,” said Dr. Danja Groves, Anesthesiologist in Charlottesville, Virginia. “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 Quantra QPlus System utilizes a fully sealed consumable cartridge to run a panel of viscoelastic blood coagulation tests. The Quantra’s patented SEER sonorheometry ultrasound technology provides fully automated testing in a closed system, enabling point of care use in busy clinical environments. Studies have demonstrated strong correlation between the Quantra and both standard laboratory tests and other viscoelastic hemostasis assays. It also introduces unique parameters, which assess platelet contribution to clot stiffness and the likelihood of residual heparin in the sample that are only available in the US on the Quantra QPlus System.

“Critical bleeding occurs frequently in cardiac and major orthopedic surgeries,” said Timothy Fischer, President and Chief Executive Officer of HemoSonics. “The Quantra QPlus System revolutionizes point-of-care management by delivering accurate and novel results in a fraction of the time required previously, near the OR, surgical suite, or ICU. Faster results can mean better management of critical bleeding, more cost-effective treatment, and ultimately better outcomes for patients.”

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