FDA approves labelling change for ExAblate Neuro System MRI-guided ultrasound in uterine fibroids- InSightec

The FDA has approved InSightec's next generation Exablate system to treat symptomatic uterine fibroids and changed the labelling to allow consideration for women who want to maintain fertility. The updated labelling specifies that ablation of uterine fibroid tissue can now be considered for women with symptomatic uterine fibroids who want to spare their uterus.

InSightec estimates that such a change in labelling provides younger women suffering from symptomatic fibroids access to a new, non-invasive treatment option that is safe, effective and keeps their uterus intact without compromising their existing ability to get pregnant. The approval is based on documented clinical data on 118 patients' pregnancies post-Exablate MRgFUS treatments. The system was first approved by the FDA for the treatment of the entire symptomatic fibroid tissue in 2009. This is the second labelling adjustment approved by the FDA since then.