Sulfur Hexafluoride

New indication of SonoVue® supports non-invasive assessment of female infertility through contrast-enhanced ultrasound in China MILAN, Aug. 5, 2025 /PRNewswire/ -- Bracco Imaging, a global leader in diagnostic imaging, today announced that its ultrasound contrast agent SonoVue® has been approved by the China's National Medical Products Administration (NMPA) for use in hysterosalpingo contrast sonography (HyCoSy). HyCoSy is a contrast-enhanced ultrasound (CEUS) procedure that helps identifying potential causes of female infertility related to blockage of the fallopian tubes or uterine abnormalities with a high level of diagnostic accuracy (1,2). Fallopian tube conditions, such as blockages, scarring, or other damage, are a leading cause of infertility, contributing to approximately 25–35 percent of cases of infertility among women in China (3). This regulatory approval represents an important milestone in the management of infertility because, unlike laparoscopic assessment of tubal patency with use of a dye, HyCoSy is a non-invasive procedure, and, unlike traditional X-ray hysterosalpingography, HyCosy does not expose to radiation the genital tract of women in their reproductive years (4-6). "The NMPA approval of SonoVue® use with HyCoSy marks an important step in expanding access to non-invasive, radiation-free detection of tubal issues and uterine problems that often cause infertility in women," said Alberto Spinazzi, Chief Medical and Regulatory Officer, Bracco Group. "We strive to provide healthcare professionals in China with solutions that advance standards of care, reflecting our commitment to advancing diagnostic precision and improving the patient experience through contrast-enhanced ultrasound." "We are proud to support China's healthcare priorities through solutions like SonoVue® that may help address important diagnostic needs," said Valtero Canepa, Head of APAC, Bracco Imaging. "This new indication advances Bracco's role in delivering meaningful innovation in support of the Healthy China 2030 initiative, which prioritizes earlier detection, clinical precision, and broader access to reproductive health services." The high diagnostic performance of HyCoSy with SonoVue® has been confirmed by a recent systematic review and meta-analysis of 24 clinical studies (total of 1358 women with infertility and 2661 fallopian tubes). Using laparoscopic chromotubation dye test as the standard of truth for the assessment of fallopian tube patency, the pooled estimates of sensitivity, specificity, and accuracy of HyCoSy with SonoVue® were 93%, 90%, and 96%, respectively (1). Backed by over 20 years of clinical use, SonoVue® is the ultrasound contrast agent with the largest number of approved indications in the largest number of countries worldwide. The newly approved HyCoSy indication reinforces Bracco Imaging's commitment to expanding non-invasive, high-quality diagnostic tools aligned with evolving clinical standards and national health objectives in China and beyond. Qu E, Zhang M, Ju J, Chen Y, Lin X, Zhang X. Is Hysterosalpingo-Contrast Sonography (HyCoSy) Using Sulfur Hexafluoride Microbubbles (SonoVue) Sufficient for the Assessment of Fallopian Tube Patency? A Systematic Review and Meta-Analysis. J Ultrasound Med 2023; 42:7-15 Wang T, Dong T, Nie F. Clinical applications, advances, and future directions in hysterosalpingography. Front Med 2025; 12:1537506 Reproductive Health Branch of Chinese Preventive Medicine Association. Chinese Expert Consensus on Holistic Management of Tubal Factor Infertility (2023 edition) [J]. Chinese Journal of Practical Gynecology and Obstetrics 2023; 39:318-324 Roy KK, Gajapathy SR, Rai R, Zangmo R, Das A, Singhal S. Assessment of Tubal Patency with Selective Chromopertubation at Office Hysteroscopy versus Modified Minilaparoscopy in Infertile Women. Gynecol Minim Invasive Ther 2021; 10:159-165 Perisinakis K, Damilakis J, Grammatikakis J, Theocharopoulos N, Gourtsoyiannis N. Radiogenic risks from hysterosalpingography. Eur Radiol 2003; 13:1522-1528 Sulieman A, Theodorou K, Vlychou M, Topaltzikis T, Roundas C, Fezoulidis I, Kappas C. Radiation dose optimisation and risk estimation to patients and staff during hysterosalpingography. Radiat Prot Dosimetry 2008;128:217-226 For additional information about Bracco's products, and for full prescribing information, please visit . About Bracco Imaging Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has 3,800 employees and operates in more than 100 markets globally. Bracco Imaging has a well skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. Discover Bracco at . Media Contacts: Bracco Press Contact: Carolina Bargoni Bracco Imaging, Communications Director [email protected] +39 347 5397738 SOURCE Bracco Imaging WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BOSTON--(BUSINESS WIRE)--A comprehensive new study based on nationwide claims data from more than 11 million patients shows that diagnostic contrast-enhanced ultrasound (CEUS) exams are safe and can lower a patient’s risk of death. The study, posted online today by the Journal of the American Heart Association, found that serious adverse events associated with ultrasound enhancing agents (UEAs) are “uncommon,” occurring in only 1:10,000 cases. This is “an exceptionally strong safety profile,” according to the study’s lead author, Dr. Jordan Strom, Associate Professor of Medicine at Harvard Medical School, Director of the Echocardiography Laboratory at Beth Israel Deaconess Medical Center, and an officer of the International Contrast Ultrasound Society (ICUS). The large, multicenter, nationwide dataset is broadly representative of US healthcare activity, according to the report. The results mirror those published a decade ago and “reassuringly suggest the continued safety of UEAs in practice,” the authors stated. “This clinically compelling study shows that CEUS is very safe, even for our sickest patients, and saves lives,” said Dr. Steven Feinstein, a cardiologist and Co-President of ICUS. CEUS is a reliable and cost-effective diagnostic tool used worldwide to diagnose heart and vascular disease, identify and characterize tumors, monitor chronic gastro-intestinal diseases, evaluate other serious medical conditions and monitor therapy, Dr. Feinstein said. He noted that, unlike contrast agents used for MR or CT, the enhancing agents used in ultrasound exams do not contain dye, create no known risk of kidney damage or brain deposits, and do not expose patients or hospital staff to ionizing radiation. In addition, CEUS exams are often easier on patients, and they provide highly accurate clinical information in real time so that appropriate therapy can be initiated without delay. Dr. Strom said that UEAs are underutilized in North America despite their well-established clinical and economic benefits, and he called upon more medical centers to offer CEUS to their patients. “UEAs can help us get the right diagnosis upfront, reducing unnecessary and costly downstream testing – and that is not only great for patients, it also helps improve health care cost containment and efficiencies, providing a unique win-win opportunity to save money while actually improving clinical care and outcomes,” Dr. Strom added. CEUS is also safe and useful for a wide range of radiology applications, said Dr. Stephanie Wilson, a radiologist at the University of Calgary and Co-President of ICUS. “We use CEUS every day because it safely and consistently provides high resolution images comparable to – and sometimes better than – CT or MR,” Dr. Wilson said. “Many of our patients cannot tolerate CT or MR, especially if they have kidney disease, so for them CEUS may be the only option for advanced imaging,” she added. Key findings of the newly-published study, which covered a four-year period between 2018 and 2022, include: Serious adverse events associated with UEAs were uncommon (occurring in only 1:10,000 administrations). This relatively low risk was similar across brands of UEAs and years of study. This risk also was consistent with findings of older studies. Patients who received UEAs are often sicker than those who don’t receive them. Still, after accounting for differences among individuals, patients who received UEAs had lower risk of death within 2 days of receiving UEAs during an echocardiogram when compared to patients who did not receive UEAs during an echocardiogram. The authors examined rates of anaphylaxis, myocardial infarction, ventricular tachycardia, cardiac arrest or death within 2 days of echocardiograms administered with and without UEAs. The study concluded that the small rate of serious adverse events should be interpreted in the context of higher risks posed by other contrast media and thus should not preclude use. The authors also cautioned that appropriate processes should be in place to mitigate risk and respond urgently to potential anaphylactoid reactions. A smaller study recently suggested that COVID-19 vaccinations may be linked to higher risk of serious adverse events with a single UEA, but the new nationwide analysis found no such link -- regardless of the agent or year of study evaluated, Dr. Strom said. “Our findings should alleviate any residual safety concerns and make a strong case for broader use of UEAs in order to improve patient care and outcomes and save lives,” Dr. Strom said. Three UEAs are currently approved by the US Food and Drug Administration for use in the United States: Definity (Lantheus); Lumason (Bracco Imaging) and Optison (GE Healthcare). ABOUT ICUS: The International Contrast Ultrasound Society (ICUS) is a nonprofit medical society dedicated to advancing the safe and medically appropriate use of contrast enhanced ultrasound (CEUS) to improve patient care globally. Membership in ICUS is free of charge and there is no fee for ICUS CME-accredited educational programs, newsletters or other resources. To join ICUS and learn more about CEUS, download ICUS Connect and visit the ICUS website (www.icus-society.org).