Quantra Hemostasis System by HemoSonics Gets FDA 510(k) Clearance

Quantra Hemostasis System by HemoSonics Gets FDA 510(k) Clearance

HemoSonics received FDA 510(k) clearance for their point-of-care and laboratory-based whole blood hemostasis testing device. Photos (not to scale with each other) of the Quantra Hemostasis System (left) with QStat Cartridge (right), courtesy of HemoSonics.

Last week, HemoSonics, LLC announced in a press release that their Quantra Hemostasis System with new QStat Cartridge was granted 510(k) market clearance by the US Food and Drug Administration (FDA). HemoSonics is a medical device company that develops personalized diagnostic solutions for patient blood management (PBM), and the addition of the QStat Cartridge to their existing Hemostasis System enables it to cover the broadest range of clinical indications in the US.

The Quantra Hemostasis System with QStat Cartridge is ground-breaking in the field of point-of-care and laboratory-based whole blood hemostasis testing, and the recent clearance expands its indications to now include trauma and liver transplant procedures.

Robert Roda, President and CEO of HemoSonics states that 510(k) clearance has created “the greatest opportunity to address the critical unmet clinical needs of our healthcare provider partners and the patients that we serve.”

Hemostasis testing can identify patients with blood defects that might result in excessive bleeding, and typically cover three phases of the blood’s clotting and wound healing process: coagulation, platelet plug formation and fibrinolysis (the breakdown of clots).

Data gathered during point-of-care can aid PBM-guided decisions. Trauma and liver transplant patients can experience better outcomes because blood product usage can be optimized with the data and facilitate the conservation of blood supplies. The hemostasis system can help clinicians determine which blood products are required to treat specific patients. Ultimately, there is a beneficial impact to public health and its costs due to the use of the Quantra Hemostasis System.

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The Technology Behind the Quantra Hemostasis System By HemoSonics

The Quantra Hemostasis System uses proprietary SEER sonorheometry, a medical-grade ultrasound technology, to measure clot stiffness of whole blood samples over time with ultrasound-induced resonance. Ultrasound pulses induce resonance in the blood sample, causing oscillation. As the blood clots over time, it will become stiffer, and thus the oscillation frequency will increase. This allows the device to measure clot times and stiffness from the sample’s elasticity.

The system quickly produces results and has dial screens that are easy to use and interpret. It is the only system specifically cleared for use in operating rooms, emergency departments and intensive care units, allowing clinicians to deliver patient-centered coagulation therapies when time is of the essence.

Currently, the Quantra System with QPlus and QStat Cartridges is commercially available in the US, Europe, Australia, New Zealand, Japan and Hong Kong.