FDA Grants HemoSonics Expanded Use of its Bleeding Management System

It enables hospitals to further standardize and operationalize viscoelastic testing.

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HemoSonics, a medical device company focused on acute bleeding management, today announced it has received Special 510(k) clearance from the 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. Today's announcement enables hospitals to further standardize and operationalize viscoelastic testing with an arterial and venous indication for both HemoSonics' QStat Cartridge and the QPlus Cartridge.

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 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 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 American Red Cross declared a blood shortage emergency in January 2024, and preserving blood is more important for medical care facilities and their communities than ever. Additionally, blood acquisition remains the most significant expense for hospital blood banks. HemoSonics' Quantra technology helps patients and hospitals by preserving precious blood supplies: a 2023 Journal of Cardiothoracic Surgery study showed that implementation of the Quantra Hemostasis Analyzer with the QPlus Cartridge reduced utilization of blood components by up to 90%, allowing greater availability for those patients truly in need. In addition, the cost of blood products decreased by 41%.

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