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HemoSonics Nabs FDA 510(k) for Cartridge-Based Blood Hemostasis Assay

NEW YORK – HemoSonics said Wednesday it secured US Food and Drug Administration 510(k) clearance for the company's QStat Cartridge assay to provide point-of-care hemostasis data during trauma and liver transplantation procedures.

Durham, North Carolina-based HemoSonics said the cartridge is designed for use in the Quantra Hemostasis System, an ultrasound-based instrument that uses sonic estimation of elasticity via resonance (SEER) sonorheometry and cartridge-based assays to measure coagulation properties in whole blood samples and aid bleeding management decisions in operating rooms, emergency departments, and intensive care units. The firm said in March 2019 it had gained FDA de novo marketing authorization for the analyzer and QPlus cartridge, which together provide viscoelastic hemostasis results within 15 minutes using a simple workflow.

Bruce Spiess, HemoSonics' medical director, said in a statement that the QStat and QPlus cartridges will help clinicians determine which blood products are needed to treat patients. The instrument and assays offer "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," he said.

The firm is also selling its instrument and cartridges in Australia, Europe, Hong Kong, Japan, and New Zealand.