HemoSonics receives clearance to expand Quantra Hemostasis System to obstetric procedures

In the U.S., about 20 mothers die for every 100,000 live births, with over 10% of these deaths caused by bleeding. The FDA recently cleared HemoSonics LLC’s Quantra Hemostasis System with QStat Cartridge for expanded use in obstetric procedures, giving doctors a new tool to help manage postpartum hemorrhage.

Durham-based HemoSonics LLC, a medical device company focused on acute bleeding management, developed the Quantra Hemostasis System to deliver real-time coagulation insights at the point of need. According to the company, the Quantra System is the first and only FDA-cleared viscoelastic testing platform for obstetric 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. 

Faster, easier decisions 

The Quantra Hemostasis System is a cartridge-based viscoelastic testing system that uses a proprietary ultrasound technology known as SEER Sonorheometry (sonic estimation of elasticity via resonance) to measure the coagulation properties of a whole blood sample. 

Healthcare clinicians can use the diagnostic information produced by the Quantra System to make individualized decisions to manage bleeding patients, optimize blood product use, and improve patient outcomes. The system requires minimal resources to maintain, is easy to operate and interpret and provides whole-blood coagulation analysis at the point of need, typically in less than 15 minutes.

“The Quantra System has the broadest range of FDA-cleared clinical indications, including cardiovascular and major orthopedic surgery, trauma and liver transplantation, and now peripartum obstetric procedures,” said Roda. 

“Now the same life-saving insight is available for obstetric clinical teams. Beyond technology, HemoSonics provides comprehensive clinical and operational support services that help hospitals implement and expand viscoelastic testing programs with confidence.”

Clinical results

A 2025 retrospective cohort study published in the International Journal of Obstetric Anesthesia showed that Quantra QStat Cartridge measurements enabled the rapid and reliable detection of blood clotting disorders during postpartum hemorrhage in 130 patients.

HemoSonics has also gained national recognition, receiving 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. 

The company’s location has played an important role in its success. "With our home office located in Durham, NC, and its proximity to the RTP area, we have access to world-class hospitals and clinicians,” said Roda. “Beyond that, the RTP hub enables HemoSonics to access a talent pool that has some of the best and the brightest minds in the MedTech fields."