HemoSonics, a medical device company focused on acute bleeding management, received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of arterial blood samples with its Quantra QStat Cartridge. HemoSonics’ QStat Cartridge used with the Quantra Hemostasis Analyzer first received 510(k) clearance from the U.S. FDA in 2022 for use in venous whole blood samples. 

This clearance 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 company says.

“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,” says Bob Roda, president and CEO of HemoSonics. “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.”

A Comprehensive Hemostasis Solution: Quantra Hemostasis System

HemoSonics’ Quantra Hemostasis System consists of 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 company says. 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.

Further reading: HemoSonics Gets Vizient Innovative Tech Contract for Quantra Hemostasis System

Evidence-Based Decisions for Patient Care

The Quantra System allows healthcare professionals to make individualized and evidence-based decisions on how to manage a bleeding patient and give a patient only medically appropriate therapy—an approach that supports global initiatives to reduce inappropriate transfusions of blood products. 

The Quantra System requires minimal resources to maintain, is easy to operate and interpret, and provides fast, comprehensive whole-blood coagulation analysis at the point of care or in laboratory-based settings, typically in less than 15 minutes, the company says.

Featured image: HemoSonics’ Quantra Hemostasis Analyzer. Photo: HemoSonics