Bracco Imaging Gains NMPA Approval for SonoVue® in Female Infertility Diagnostics

Bracco Imaging, a leading global provider of diagnostic imaging solutions, has received regulatory approval from China’s National Medical Products Administration (NMPA) for the use of its ultrasound contrast agent, SonoVue®, in hysterosalpingo contrast sonography (HyCoSy). This new indication allows for non-invasive assessment of fallopian tube patency in women experiencing infertility.

HyCoSy, a contrast-enhanced ultrasound (CEUS) procedure, enables clinicians to detect uterine and fallopian tube abnormalities with high diagnostic accuracy. Tubal factors account for roughly 25–35% of female infertility cases in China. Unlike traditional X-ray hysterosalpingography, HyCoSy with SonoVue® eliminates exposure to ionizing radiation. It also provides a less invasive alternative to laparoscopic dye testing.

Backed by data from a systematic review of 24 studies involving over 1,300 women, HyCoSy with SonoVue® demonstrated pooled sensitivity, specificity, and accuracy rates of 93%, 90%, and 96%, respectively, when compared to laparoscopic methods. This positions the technique as a reliable tool for early and accurate diagnosis in reproductive health.

Executives at Bracco Imaging underscored the significance of this approval in aligning with China’s national health goals. “This marks a critical step in improving access to radiation-free, patient-friendly infertility diagnostics,” said Dr. Alberto Spinazzi, Chief Medical and Regulatory Officer at Bracco Group. Valtero Canepa, Head of APAC, emphasized the company’s support for the Healthy China 2030 initiative, which prioritizes clinical precision and reproductive healthcare access.

SonoVue® has been in clinical use for over two decades and holds the broadest global approval footprint among ultrasound contrast agents. The addition of this new use case further strengthens Bracco’s commitment to advancing diagnostic standards and supporting better outcomes in women’s health.