HemoSonics Gains Special FDA 510(k) Clearance for Quantra QStat Cartridge

HemoSonics, a medical device company focused on acute bleeding management, has received Special 510(k) clearance from the FDA for the expanded use of arterial blood samples with its Quantra QStat Cartridge. This enables hospitals to further standardize and operationalize viscoelastic testing with an arterial and venous indication for both HemoSonics’ QStat Cartridge and the QPlus Cartridge.
 
The QStat Cartridge used with the Quantra Hemostasis Analyzer first received 510(k) clearance from the FDA in 2022 for use in venous whole blood samples. The Quantra Hemostasis System includes the Quantra Hemostasis Analyzer with QPlus and QStat Cartridges, which enable clinicians to deliver patient-centered decisions on bleeding management that improve care and optimize blood product usage. 
 
The Quantra System is FDA-cleared for use in point-of-care settings such as operating rooms, intensive care units, and in hospital laboratories, enabling hospitals to standardize use institution-wide with greater operational efficiency.
 
“The FDA 510(k) clearance for arterial blood sample use with our QStat Cartridge will make it easier and more convenient for hospitals to use the Quantra System,” said HemoSonics president and CEO, Bob Roda. “The Quantra System now has the broadest range of FDA-cleared clinical indications of any cartridge-based viscoelastic testing system. It is cleared for use in cardiac, trauma, liver, and major orthopedic surgeries. We will continue to innovate in our mission to help patients and hospitals preserve blood, which is a precious resource.”
 
The Quantra System requires minimal resources to maintain, it is easy to operate and interpret, and provides fast, comprehensive whole-blood coagulation analysis at the point of care or in laboratory-based settings.
 
The Quantra System supports global initiatives to reduce inappropriate transfusions of blood products. It allows healthcare professionals to make individualized and evidence-based decisions on how to manage a bleeding patient.