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FDA Grants HemoSonics Special 510(k) Clearance for Expanded Utilization of Critical Bleeding Management System

Thursday, April 04, 2024

HemoSonics, a medical device company specializing in acute bleeding management, has announced the receipt of a Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanding the use of arterial blood samples with its Quantra QStat® Cartridge. Originally cleared for venous whole blood samples in 2022, the Quantra Hemostasis Analyzer, along with the QStat Cartridge, can now be utilized with both arterial and venous indications.

This clearance empowers hospitals to further standardize and streamline viscoelastic testing, facilitating efficient utilization of both the QStat Cartridge and the QPlus® Cartridge across various clinical settings. By extending the clearance to include arterial blood samples, the Quantra System broadens its clinical applicability, catering to cardiac, trauma, liver, and major orthopedic surgeries.

The expanded clearance reflects HemoSonics' dedication to innovation in bleeding management, aiming to assist both patients and hospitals in conserving blood resources. The Quantra Hemostasis System, comprising the Quantra Hemostasis Analyzer and its associated cartridges, enables clinicians to make timely and personalized decisions regarding bleeding management, ultimately improving patient care and optimizing blood product usage.

With FDA clearance for point-of-care use in operating rooms, intensive care units, and hospital laboratories, the Quantra System offers operational efficiency and standardization across healthcare institutions. This approach aligns with global initiatives to reduce unnecessary blood product transfusions, ensuring that patients receive only medically necessary therapies.

The Quantra System's user-friendly design, minimal resource requirements, and rapid whole-blood coagulation analysis further contribute to its suitability for both point-of-care and laboratory-based settings, typically providing results within 15 minutes.


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