Durham, N.C., September 25, 2025 – HemoSonics LLC, a medical device innovator in acute bleeding management, has received 510(k) clearance from the U.S. FDA to extend its Quantra® Hemostasis System to obstetric procedures. This approval makes Quantra the first and only FDA-cleared viscoelastic testing (VET) platform for maternal bleeding, offering clinicians rapid, real-time insights to guide critical decisions during childbirth
Science Significance
Postpartum hemorrhage (PPH) is a leading contributor to maternal mortality globally, affecting roughly 14 million women annually and resulting in approximately 70,000 deaths. In the U.S., maternal deaths linked to bleeding occur in over 10% of cases, with a rate nearly twice the OECD average. The Quantra System uses SEER Sonorheometry, a proprietary ultrasound-based technology, to measure the coagulation properties of whole blood in less than 15 minutes, allowing immediate, data-driven clinical interventions. This capability represents a breakthrough in point-of-care diagnostics, providing individualized information for safer obstetric care.
Regulatory Significance
FDA 510(k) clearance highlights the safety, accuracy, and effectiveness of the Quantra System in obstetric procedures. Previously cleared for major orthopedic, cardiovascular, trauma, and liver transplantation applications, Quantra now addresses a critical unmet need in maternal health, cementing its regulatory credibility across multiple acute care settings. This clearance also underscores the FDA’s commitment to supporting innovative technologies that address maternal mortality and hemorrhage management.
Business Significance
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By expanding Quantra into obstetrics, HemoSonics positions itself as a leader in point-of-care coagulation diagnostics. The system’s fast, reliable, and easy-to-use platform enhances hospital workflows, reduces unnecessary blood product usage, and optimizes clinical efficiency. Recognition through the 2024 NIH RADx Tech for Maternal Health Challenge further validates HemoSonics’ innovation, potentially driving adoption across both domestic and global markets.
Patients’ Significance
For women experiencing severe postpartum bleeding, the Quantra System is a game-changer. Rapid, real-time coagulation insights enable clinicians to intervene promptly, potentially reducing maternal mortality, transfusions, and complications. The technology’s ease of use and accuracy at the point of care empowers healthcare teams to make informed, timely decisions that directly enhance maternal outcomes and patient safety.
Policy Significance
Maternal health remains a priority in public health policy worldwide. FDA clearance of the Quantra System aligns with global initiatives to reduce preventable maternal deaths and strengthen evidence-based hemorrhage management protocols. By enabling point-of-care testing and facilitating rapid clinical decision-making, the technology supports policy goals aimed at improving maternal care standards, hospital preparedness, and health equity.
Transaction Highlights
HemoSonics’ FDA 510(k) clearance for the Quantra Hemostasis System in obstetric procedures marks a major regulatory and commercial milestone for the company. The system, now the first and only FDA-cleared viscoelastic testing platform for maternal bleeding, provides rapid, real-time coagulation analysis at the point of care, enabling clinicians to make immediate, data-driven decisions during childbirth. The QStat Cartridge delivers comprehensive insights in under 15 minutes, helping care teams assess and manage severe postpartum hemorrhage with greater accuracy and confidence. Beyond the technology itself, HemoSonics offers operational and clinical support to ensure hospitals can implement and expand viscoelastic testing programs effectively. This clearance extends the Quantra System’s clinical reach from cardiovascular, trauma, and surgical applications to obstetrics, highlighting its versatility and reinforcing HemoSonics’ commitment to improving maternal outcomes and reducing mortality worldwide.
Source: HemoSonics LLC Press Release
