Bracco Imaging Receives NMPA Approval for SonoVue in Female Infertility Assessment in China
Key Insights
Bracco Imaging (search)'s ultrasound contrast agent SonoVue has received approval from China's National Medical Products Administration for use in hysterosalpingo contrast sonography (HyCoSy) to assess female infertility.
The non-invasive procedure offers a radiation-free alternative to traditional X-ray hysterosalpingography for detecting fallopian tube blockages and uterine abnormalities that contribute to 25-35% of infertility cases in Chinese women.
Clinical evidence from 24 studies involving 1,358 women demonstrates HyCoSy with SonoVue achieves 93% sensitivity, 90% specificity, and 96% accuracy in assessing fallopian tube patency.
Bracco Imaging (search) announced that China's National Medical Products Administration (NMPA) has approved its ultrasound contrast agent SonoVue for use in hysterosalpingo contrast sonography (HyCoSy), marking a significant advancement in non-invasive female infertility assessment. The approval enables healthcare professionals in China to utilize this radiation-free diagnostic procedure for identifying potential causes of infertility related to fallopian tube blockages and uterine abnormalities.
Clinical Significance and Diagnostic Performance
HyCoSy represents a crucial diagnostic tool for female infertility evaluation, as fallopian tube conditions including blockages, scarring, and other damage contribute to approximately 25-35 percent of infertility cases among women in China. The procedure's clinical efficacy has been validated through comprehensive research involving 24 clinical studies encompassing 1,358 women with infertility and 2,661 fallopian tubes.
Using laparoscopic chromotubation dye test as the reference standard for assessing fallopian tube patency, the systematic review and meta-analysis demonstrated that HyCoSy with SonoVue achieved pooled estimates of 93% sensitivity, 90% specificity, and 96% accuracy. These performance metrics establish the procedure as a highly reliable diagnostic method for reproductive health assessment.
Advantages Over Traditional Methods
The regulatory approval represents an important milestone in infertility management due to HyCoSy's distinct advantages over conventional diagnostic approaches. Unlike laparoscopic assessment of tubal patency using dye, HyCoSy is a non-invasive procedure that eliminates surgical risks and patient discomfort. Additionally, unlike traditional X-ray hysterosalpingography, HyCoSy does not expose the genital tract of women in their reproductive years to ionizing radiation.
"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 at 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."
Strategic Alignment with Healthcare Initiatives
The approval aligns with China's broader healthcare objectives, particularly the Healthy China 2030 initiative, which prioritizes earlier detection, clinical precision, and broader access to reproductive health services. Valtero Canepa, Head of APAC at Bracco Imaging (search), emphasized the company's commitment to supporting China's healthcare priorities through innovative diagnostic solutions.
"We are proud to support China's healthcare priorities through solutions like SonoVue that may help address important diagnostic needs," Canepa stated. "This new indication advances Bracco's role in delivering meaningful innovation in support of the Healthy China 2030 initiative."
Product Background and Global Presence
SonoVue is backed by over 20 years of clinical use and holds the distinction of being the ultrasound contrast agent with the largest number of approved indications across the most countries worldwide. The newly approved HyCoSy indication reinforces Bracco Imaging (search)'s commitment to expanding non-invasive, high-quality diagnostic tools that align with evolving clinical standards and national health objectives in China and internationally.
Bracco Imaging (search), headquartered in Milan, Italy, operates as a global leader in diagnostic imaging with 3,800 employees serving more than 100 markets worldwide. The company maintains a comprehensive portfolio across diagnostic imaging modalities, including X-ray imaging, magnetic resonance imaging (MRI), contrast-enhanced ultrasound (CEUS), and nuclear medicine through radioactive tracers and novel PET imaging agents.