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 . 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 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
“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.”