January 2023—HemoSonics has received FDA 510(k) clearance for the Quantra hemostasis system with QStat cartridge. The clearance of the QStat cartridge expands the Quantra system’s indications for use to include trauma and liver transplant procedures.
“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,” Bruce Spiess, MD, medical director of HemoSonics, said in a company press release. “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 uses sonic estimation of elasticity via resonance (SEER) sonorheometry, an ultrasound technology, to measure the coagulation properties of a whole blood sample. The Quantra with QPlus and QStat cartridges is commercially available in the United States, Europe, Australia, New Zealand, Japan, and Hong Kong.
HemoSonics, 800-280-5589