Hemosonics-Hero-mobile-blood-dials
March 13, 2019

FDA grants de novo for the HemoSonics’ Quantra® QPlus® System; This Revolutionary Diagnostic Provides Unique Information for Assessing Coagulation at the Point of Care; Now Commercially Available in US

Charlottesville, VA, January 19, 2021 – HemoSonics welcomes the January 14th guidance of the US Food and Drug Administration (FDA) that broadens the use of viscoelastic coagulation analyzers for hospital patient healthcare settings in response to COVID-19. The FDA guidance is intended, for the duration of the COVID-19 public health emergency, to expand the availability of coagulation systems for measurement of whole blood viscoelastic properties to assess hemostasis.1

Charlottesville, VA – March 13, 2019 – HemoSonics today 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 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.”

Availability

The Quantra QPlus System is commercially available in the U.S. and Europe.

About HemoSonics

HemoSonics is a medical device company with the primary mission to deliver clinical tools that provide actionable information in the critical care setting; resulting in better care for patients and lower overall medical costs.

The Quantra Hemostasis Analyzer, the flagship product from HemoSonics, is designed to support these goals. It is designed to improve patient outcomes and reduce healthcare costs by providing unique and optimized information, for easy and fast interpretation and simple, more efficient Point of Care workflows related to bleeding management.

HemoSonics is headquartered in Charlottesville, VA, with research, development and manufacturing facilities in Durham, NC. For more information, visit www.hemosonics.com.

HemoSonics is owned by the Stago group, a leading company in the In-Vitro Diagnostics industry dedicated to the exploration of thrombosis and hemostasis.

For more information, please contact:

Lee DeGeer
VP Marketing
(919) 504-1030
Hemosonics.com