The cartridge-based viscoelastic testing platform provides rapid coagulation analysis to help clinicians manage postpartum hemorrhage.
The US Food and Drug Administration (FDA) has granted 510(k) clearance for expanded use of HemoSonics’ Quantra Hemostasis System with QStat Cartridge in peripartum obstetric procedures.
The Quantra Hemostasis System delivers real-time coagulation analysis at the point of care, providing clinicians with data to help manage women at risk of postpartum hemorrhage during childbirth. The system typically provides results in less than 15 minutes.
Severe bleeding after childbirth represents the leading cause of maternal mortality globally, according to the World Health Organization. Approximately 14 million women worldwide experience postpartum hemorrhage annually, resulting in roughly 70,000 deaths. In the US, maternal mortality rates reach 21.1 deaths per 100,000 live births, nearly twice the Organization for Economic Cooperation and Development average, with more than 10% of maternal deaths attributed 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,” says Bob Roda, president and CEO of HemoSonics, in a release.
SEER Sonorheometry Technology
The Quantra System uses SEER Sonorheometry (sonic estimation of elasticity via resonance), a proprietary medical-grade ultrasound technology that measures coagulation properties of whole blood samples. The system includes the Quantra Hemostasis Analyzer with QPlus and QStat Cartridges.
The platform requires minimal maintenance resources and provides whole-blood coagulation analysis designed to help clinicians make individualized decisions regarding bleeding patient management and blood product optimization.
The system already has FDA clearance for cardiovascular and major orthopedic surgery, trauma, and liver transplantation in point-of-care and laboratory settings.
Clinical Validation and Recognition
HemoSonics received the grand prize in the 2024 National Institutes of Health RADx Tech for Maternal Health Challenge, which seeks to accelerate development of diagnostic tools addressing maternal mortality.
A 2025 retrospective cohort study published in the International Journal of Obstetric Anesthesia demonstrated that Quantra QStat Cartridge parameters enabled rapid and reliable detection of blood-clotting disorders during postpartum hemorrhage in 130 patients.
“Beyond technology, HemoSonics provides clinical and operational support services that help hospitals implement and expand viscoelastic testing programs with confidence,” says Roda in a release.
Photo caption: Woman with newborn in hospital
Photo credit: HemoSonics
