China’s National Medical Products Administration (NMPA) has approved Bracco Imaging’s ultrasound contrast agent, sulphur hexafluoride (SF6) microbubbles, for use in a contrast-enhanced ultrasound (CEUS) procedure that aids in the diagnosis of female infertility.
The hysterosalpingo-contrast-sonography (HyCoSy) procedure is instrumental in detecting potential reasons for infertility associated with fallopian tube blockages or uterine abnormalities.
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Utilising SF6 microbubbles, HyCoSy is said to offer a non-invasive and radiation-free diagnostic alternative to traditional methods such as tubal patency’s laparoscopic assessment and X-ray hysterosalpingography.
The diagnostic performance of the procedure with SF6 microbubbles claims to have been validated by a systematic review and meta-analysis of 24 trials, encompassing 1,358 females with infertility issues and 2661 fallopian tubes.
When evaluating the patency of fallopian tubes, the laparoscopic chromotubation dye test is considered the benchmark. The combination of HyCoSy with a contrast agent showed a pooled estimate of sensitivity of 93%, a specificity of 90%, and an accuracy of 96%.
According to the company, fallopian tube blockages and scarring contribute to a substantial proportion of infertility cases among Chinese women.
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By GlobalDataBracco Imaging noted that its focus on expanding non-invasive diagnostic tools is further exemplified by its global presence, with SF6 being the ultrasound contrast agent with the most approved indications in numerous nations.
Bracco Group medical and regulatory officer Alberto Spinazzi said: “The NMPA approval of SF6 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.
“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.”
In June 2025, Bracco Imaging and Subtle Medical secured a European Union (EU) CE mark for AiMIFY, a co-developed software designed to enhance the imaging of contrast MRI brain scans using AI.
Last year, Bracco Imaging and medical device company BURL Concepts partnered to improve ischemic stroke detection and patient care.
