HemoSonics Wins FDA Clearance for device aimed at reducing maternal deaths from childbirth bleeding

HemoSonics device aims to reduce maternal deaths: ©HemoSonics

HemoSonics LLC announced it has received clearance from the U.S. Food and Drug Administration to expand the use of its Quantra Hemostasis System with QStat Cartridge to include peripartum obstetric procedures.

The system provides clinicians with rapid, real-time data to assess and manage coagulation in women at risk of postpartum hemorrhage, the leading cause of maternal mortality worldwide. It is the first and only cartridge-based viscoelastic testing platform cleared by the FDA for obstetric bleeding, according to the company.

Severe bleeding after childbirth affects about 14 million women annually and is responsible for roughly 70,000 deaths globally, the World Health Organization reports. In the U.S., maternal mortality rates are nearly double the average of other developed nations, with hemorrhage contributing to more than 10% of maternal deaths.

“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,” Bob Roda, president and CEO of HemoSonics, said in a statement.

The Quantra system, which uses proprietary ultrasound technology to analyze whole blood samples, has previously been cleared for use in cardiovascular and orthopedic surgery, trauma and liver transplantation. The company said its technology can deliver results in less than 15 minutes, helping providers optimize blood product use and improve patient outcomes.

HemoSonics’ system won the grand prize in the 2024 National Institutes of Health RADx Tech for Maternal Health Challenge, which aims to foster solutions to address maternal mortality.

Advances in maternal hemorrhage management

The clearance highlights a growing focus in health care on combating postpartum hemorrhage (PPH), a condition that continues to drive maternal deaths both in the U.S. and abroad. Recent advances in this field emphasize earlier detection, faster response times and more personalized approaches to care.

One area of progress has been the integration of point-of-care diagnostics into labor and delivery suites. Instead of relying solely on standard laboratory testing, which can delay decision-making, new tools allow clinicians to evaluate a patient’s coagulation status within minutes. This speed is particularly important in PPH, where outcomes hinge on rapid recognition and treatment.

Another advance involves broader adoption of viscoelastic testing (VET) technologies, which provide a dynamic picture of how blood clots form and break down. Unlike conventional lab tests that capture only static measures, VET systems deliver a more comprehensive profile of coagulation. This helps clinicians tailor transfusions and interventions to individual patients rather than relying on one-size-fits-all protocols.

Research is also pointing toward the value of combining diagnostic insights with structured care pathways. Hospitals are increasingly adopting standardized hemorrhage protocols that integrate advanced monitoring tools with checklists and team-based responses. The combination has been shown to reduce unnecessary transfusions and lower complication rates.

Finally, global health initiatives are pushing for scalable solutions that can be deployed not only in high-resource hospitals but also in lower-resource settings where maternal mortality rates are highest. Innovations that require minimal maintenance, are portable, and can be operated with limited training are gaining traction as part of international efforts to narrow disparities in maternal health.

Together, these advances reflect a wider recognition that reducing maternal deaths from hemorrhage requires both technological innovation and systemic changes in how obstetric emergencies are managed.