DURHAM, N.C.--(BUSINESS WIRE)--Sep 25, 2025--
HemoSonics LLC, a medical device company focused on acute bleeding management, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of 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 women at risk of experiencing postpartum hemorrhage during childbirth. Quantra is the first and only cartridge-based, FDA-cleared viscoelastic testing (VET) platform for obstetric bleeding.
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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 just 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,” said HemoSonics’ President and CEO Bob Roda. “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 innovative SEER Sonorheometry (sonic estimation of elasticity via 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 regarding the management of bleeding patients, optimize blood product use, and improve 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.
“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,” added Roda. “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.
Email contact@hemosonics.com to learn more about HemoSonics’ Quantra Hemostasis System or visit https://hemosonics.com.
About HemoSonics
HemoSonics, LLC is a medical device technology company focused on acute bleeding management, resulting in better patient care and lower overall medical costs. The Quantra Hemostasis Analyzer, HemoSonics' flagship product, is designed to improve patient outcomes and reduce healthcare costs by providing optimized coagulation information. The Quantra System's easy and fast interpretation enables simple, more efficient point-of-care and laboratory bleeding management.
Based in Durham, NC, HemoSonics is part of the Stago Group, a leading in vitro diagnostics company dedicated to exploring thrombosis and hemostasis. Follow HemoSonics on LinkedIn or visit HemoSonics.com to learn more.
A mother hugging her newborn baby in a hospital shortly after labor and giving birth. (Source: Natalia Deriabina, Shutterstock)
HemoSonics Quantra Hemostasis System provides comprehensive blood analysis. It delivers rapid, real-time coagulation insights at the point of need, empowering clinicians with actionable data to make better decisions and protect mothers who experience postpartum hemorrhage during childbirth. Quantra is the first and only cartridge-based FDA-cleared viscoelastic testing platform for obstetrics. (Source: HemoSonics)
WASHINGTON (AP) — President Donald Trump’s military intervention in Venezuela will pose a fresh test of his ability to hold together a restive Republican coalition during a challenging election year that could be defined by domestic concerns like health care and affordability.
While most Republicans lined up behind the president in the immediate aftermath of the stunning U.S. mission to capture Venezuelan leader Nicolás Maduro and bring him to New York to face criminal charges, there were signs of unease across the spectrum within the party. In particular, Trump's comments about the U.S. positioning itself to “run” Venezuela have raised concerns that he is abandoning the “America First” philosophy that has long distinguished him from more traditional Republicans and helped fuel his political rise.
“This is the same Washington playbook that we are so sick and tired of that doesn't serve the American people, but actually serves the big corporations, the banks and the oil executives,” said Rep. Marjorie Taylor Greene of Georgia, a former Trump ally who is resigning on Monday, in an interview with NBC's “Meet the Press” on Sunday.
Those concerns were shared by some who are not associated with the party's far-right flank.
Rep. Brian Fitzpatrick of Pennsylvania, a moderate who is one of the most vulnerable Republicans in the November midterms, said in a statement that “the only country that the United States of America should be ‘running’ is the United States of America.”
Those comments reflect the sensitive dynamics between Trump and his fellow Republicans at the outset of an election year in which their party risks losing control of Congress. While the president's dominance remains undisputed, the ironclad grip that he has held over the party has faced unusual challenges in recent months. Blocs of Republicans have banded together to pressure Trump to release the Jeffrey Epstein files. Others have been vocal in encouraging Trump to take concerns about affordability more seriously.
Few issues are as central to Trump's political brand as ensuring that the U.S. does not get entangled in seemingly endless foreign conflicts at the expense of domestic goals. During a 2016 Republican presidential debate, for instance, he described the war in Iraq as a “big, fat mistake."
But on Saturday, Trump said he was “not afraid of boots on the ground” in Venezuela if that was deemed necessary, and he framed his actions as prioritizing the safety and security of Americans. He articulated an aggressive vision of U.S. dominance in the Western Hemisphere, and he told reporters it was important to “surround ourselves with good neighbors."
However, much like the Iraq War, a president's early confidence after a dramatic military action can sometimes meet more sobering realities that drain domestic political support.
In Venezuela, U.S. troops could be placed in harm's way again as Trump warns that more military operations may be in the works. An ongoing conflict could worsen the hemisphere's refugee crisis, something the White House has tried to tamp down with stricter border controls. In addition, there are questions about how much cooperation the U.S. will receive from officials still in Venezuela or how easily the country's oil reserves could be tapped to fulfill Trump's goal of extracting more energy with Maduro out of the picture.
Trump's comments this weekend about revitalizing the oil industry in Venezuela are in line with some of the earliest critiques he made of the handling of the Iraq War. During a 2013 speech before the Conservative Political Action Conference, Trump said the U.S. should “take” oil from Iraq and “pay ourselves back.”
Frustration with the handling of the Iraq War contributed to major gains for Democrats in the 2006 election and helped create the conditions for Barack Obama to be elected to the presidency two years later. Given the baggage surrounding those wars, Trump allies insist that the actions this weekend in Venezuela are different.
“Venezuela looks nothing like Libya,” Secretary of State Marco Rubio said on “Meet the Press. “It looks nothing like Iraq. It looks nothing like Afghanistan. It looks nothing like the Middle East other than the Iranian agents that are running through there plotting against America, okay?”
Senate Intelligence Committee Chairman Tom Cotton argued that the 1989 ouster of Manuel Noriega in Panama is a better comparison.
“That was a successful operation,” Cotton said on CNN's “State of the Union.” “I believe, in the long run, this will be too.”
Still, amid some of the pushback about the U.S. taking expansive responsibility for managing Venezuela, Rubio suggested a more limited role. He said that Washington would not handle day-to-day governance of the South American country other than enforcing an existing “oil quarantine” on Venezuela.
It is not clear that any forceful, organized opposition to Trump's Venezuela policy is emerging within the GOP. Instead, many lawmakers appear to be giving the Republican administration some room and, at most, offer some warnings.
Sen. Susan Collins of Maine, who faces a potentially challenging reelection campaign this year, called Maduro a “narco-terrorist and international drug trafficker” who should stand trial even, as she said “Congress should have been informed about the operation earlier and needs to be involved as this situation evolves.”
Even Sen. Rand Paul of Kentucky, who often criticizes military interventions, did not specifically oppose Trump's actions. He wrote on social media that “time will tell if regime change in Venezuela is successful without significant monetary or human cost.”
Many Democrats denounced Trump's actions in Venezuela and the Democratic National Committee quickly sought to raise money by blasting “another unconstitutional war from Trump.”
Rep. Alexandria Ocasio Cortez, D-N.Y., rejected the administration's argument that it was combating drug crimes, saying on X that the White House is instead focused on “oil and regime change” while seeking to “to distract from Epstein + skyrocketing healthcare costs.” Former Transportation Secretary Pete Buttigieg said the strike was part of an “old and obvious pattern” where an “unpopular president — failing on the economy and losing his grip on power at home — decides to launch a war for regime change abroad.”
AP Diplomatic Writer Matthew Lee contributed to this report.
President Donald Trump speaks at his Mar-a-Lago club, Saturday, Jan. 3, 2026, in Palm Beach, Fla., as Defense Secretary Pete Hegseth listens. (AP Photo/Alex Brandon)
President Donald Trump listens to a question during a news conference at Mar-a-Lago, Saturday, Jan. 3, 2026, in Palm Beach, Fla., as Secretary of State Marco Rubio watches. (AP Photo/Alex Brandon)
