DURHAM, N.C.– HemoSonics LLC, a medical device company specializing in acute bleeding management, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the use of its Quantra Hemostasis System with QStat Cartridge to obstetric procedures.
The Quantra System provides rapid, real-time coagulation insights at the point of care, equipping clinicians with actionable data to make informed decisions and protect women at risk of postpartum hemorrhage during childbirth. With this approval, Quantra becomes the first and only cartridge-based, FDA-cleared viscoelastic testing platform available for obstetric bleeding.
Postpartum hemorrhage remains the leading cause of maternal mortality worldwide. According to the World Health Organization, about 14 million women experience severe bleeding after childbirth each year, leading to approximately 70,000 deaths. In the United States, maternal mortality rates are nearly double the OECD average, with more than 10 percent of deaths linked to bleeding.
“The expansion of the Quantra Hemostasis System to the obstetric population will empower clinicians with crucial, real-time, actionable data to help care teams quickly assess and manage severe bleeding in women at risk for postpartum hemorrhage after childbirth,” said HemoSonics President and CEO Bob Roda. “HemoSonics is setting a new standard for ease of use, speed and accuracy at the point of need. We’re committed to fighting the maternal mortality crisis worldwide by advancing technology that helps women have safe and healthy deliveries.”
The Quantra Hemostasis System includes the Quantra Hemostasis Analyzer with QPlus and QStat Cartridges and is powered by SEER Sonorheometry, a proprietary ultrasound-based technology that measures the coagulation properties of whole blood. By providing rapid diagnostic insights, typically in less than 15 minutes, the system enables individualized, evidence-based decisions to optimize blood product use and improve patient outcomes.
“The Quantra System has the broadest range of FDA-cleared clinical indications, including cardiovascular and major orthopedic surgery, trauma and liver transplantation in both point-of-care and laboratory settings,” Roda added. “Now the same life-saving insight is available for obstetrics. Beyond technology, HemoSonics provides comprehensive clinical and operational support services that help hospitals implement and expand viscoelastic testing programs with confidence.”
HemoSonics was awarded the grand prize in the 2024 National Institutes of Health (NIH) RADx Tech for Maternal Health Challenge for its innovation in diagnostic solutions to address maternal mortality. A recent study published in the International Journal of Obstetric Anesthesia further validated the system, showing that the Quantra QStat Cartridge reliably detected clotting disorders during postpartum hemorrhage in 130 patients.
