#China #Milan #Bracco Imaging #SonoVue #HyCoSy

Bracco Imaging's SonoVue® Gaining Approval in China

Bracco Imaging, a prominent name in the field of diagnostic imaging, has secured regulatory approval from China’s National Medical Products Administration (NMPA) for its ultrasound contrast agent, SonoVue®. This new approval facilitates the use of SonoVue® in hysterosalpingo contrast sonography (HyCoSy), a significant step towards addressing female infertility issues in the region.

The HyCoSy procedure stands out as a non-invasive ultrasound technique designed to assess the patency of the fallopian tubes—helpful in diagnosing possible infertility causes. Infertility can be caused by various factors, but blockages or scarring in the fallopian tubes are notably responsible for 25–35% of infertility cases among women in China. Thus, having a reliable non-invasive option to evaluate these conditions is critical.

Bracco's innovative approach with SonoVue® is compelling due to its radiation-free nature; unlike the traditional X-ray hysterosalpingography, HyCoSy allows for the accurate diagnosis without exposing women to potentially harmful ionizing radiation during their reproductive years. This is a substantial advancement in women's health, providing both healthcare professionals and patients with a safer option for diagnosis.

Alberto Spinazzi, the Chief Medical and Regulatory Officer of Bracco Group, emphasized the importance of this development, stating, "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."

Such developments are crucial as they align with healthcare goals in China, particularly in aiding the Healthy China 2030 initiative, which focuses on enhancing early detection, clinical precision, and improving access to reproductive health services. Valtero Canepa, Head of APAC for Bracco Imaging, highlighted that this new indication is pivotal for addressing substantial diagnostic needs within the country.

Recent systematic reviews, consisting of extensive clinical studies, ascertain the high diagnostic efficacy of HyCoSy with SonoVue®. The cumulative results reveal an impressive sensitivity of 93%, specificity of 90%, and accuracy of 96% when comparing against the laparoscopic chromotubation dye test, a traditional method for determining fallopian tube patency. These statistics underscore the reliability and strategic role of SonoVue® in modern fertility treatments.

Backed by over two decades of clinical utilization and recognized as having the largest number of approved indications globally, SonoVue® underpins Bracco Imaging's commitment to providing advanced non-invasive diagnostic solutions. This recent regulatory endorsement fortifies the company’s goal to elevate the standards of care in diagnostic imaging while evolving to meet national health objectives both in China and worldwide.

Bracco Imaging aims not only to enhance diagnostic accuracy but also to facilitate better patient experiences through its strategic developments like SonoVue®. With a rapidly evolving healthcare landscape, the company is resolute in its mission to push boundaries in imaging technology, setting new benchmarks that align with patient-centered care. Bracco’s advancements signify a leap toward comprehensive healthcare solutions, making them integral in supporting women’s reproductive health in China.

For further details about Bracco's offerings, feel free to visit Bracco's official site.