HemoSonics, a medical device company focused on acute bleeding management, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its Quantra Hemostasis System with QStat Cartridge in peripartum obstetric procedures. The Quantra Hemostasis System delivers rapid, real-time coagulation insights at the point of need, empowering clinicians with actionable data to make confident decisions and protect women at risk of experiencing postpartum hemorrhage during childbirth. Quantra is the first and only cartridge-based, FDA-cleared viscoelastic testing (VET) platform for obstetric bleeding.
HemoSonics pioneered the first cartridge-based viscoelastic testing system—the Quantra Hemostasis System—which includes the Quantra Hemostasis Analyzer with QPlus and QStat Cartridges. The Quantra System uses innovative SEER Sonorheometry (sonic estimation of elasticity via resonance), a proprietary medical-grade ultrasound technology that measures the coagulation properties of a whole blood sample. The diagnostic insights produced by Quantra enable healthcare clinicians to make individualized and evidence-based decisions regarding the management of bleeding patients, optimize blood product use, and improve patient outcomes. 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 need, typically in less than 15 minutes.
HemoSonics
HemoSonics received the grand prize in the 2024 National Institutes of Health (NIH) RADx Tech for Maternal Health Challenge, which seeks to accelerate the development of innovative diagnostic tools and solutions that address maternal mortality. A recent retrospective cohort study published in the International Journal of Obstetric Anesthesia demonstrated that Quantra QStat Cartridge parameters enabled the rapid and reliable detection of blood-clotting disorders during postpartum hemorrhage in 130 patients.
