FDA Clears HemoSonics’ Quantra Hemostasis System for Expanded Use

HemoSonics LLC has received U.S. Food and Drug Administration (FDA) 510(k) clearance to use 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 against postpartum hemorrhage during childbirth. Quantra is reportedly the first and only FDA-cleared viscoelastic testing (VET) platform for obstetric bleeding.

Severe bleeding after childbirth is the leading cause of maternal mortality globally, according to the World Health Organization. Roughly 14 million women worldwide experience postpartum hemorrhage (PPH) annually, resulting in approximately 70,000 deaths. The problem does not only affect developing nations—the United States reports 21.1 deaths per 100,000 live births, almost twice the Organization for Economic Cooperation and Development average, with more than 10% of maternal deaths due 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,” HemoSonics President/CEO Bob Roda said. “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.”

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 SEER Sonorheometry (sonic estimation of elasticity through 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 about managing bleeding in patients, optimizing blood product use, and improving 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, company bigwigs claim.

Related: HemoSonics Quantra Wins 2025 Life Sciences Award

“The Quantra System has the broadest range of FDA-cleared clinical indications, including cardiovascular and major orthopedic surgery, trauma and liver transplantation in 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 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.

HemoSonics LLC is a medical device technology company focused on acute bleeding management. The Quantra Hemostasis Analyzer, HemoSonics’ flagship product, is designed to improve patient outcomes and reduce healthcare costs by providing optimized coagulation information. Based in Durham, N.C., HemoSonics is part of the Stago Group, an in-vitro diagnostics company exploring thrombosis and hemostasis.