News

Sort By

MR-guided focused ultrasound (MRgFUS) developer INSIGHTEC has received U.S. Food and Drug Administration (FDA) clearance for a new version of its Exablate device and a change in labeling.

The new version of system is cleared for the treatment of symptomatic uterine fibroids, and with the updated labeling, fibroid tissue ablation can now be considered for patients who wish to retain fertility, the company said. Link to full article.

INSIGHTEC announced on Wednesday that the FDA has approved the relabeling of the Exablate system to treat women with symptomatic uterine fibroids who want to spare their uterus and maintain fertility. Exablate can now be used for both women who are “family complete” and those who still want to conceive. Link to article

Radiology Today’s June feature article publicized a great overview of MRgFUS technology – its current applications in the US and globally, as well as future applications. The article also provides the experiences and points of view of several U.S. champions of the technology, such as Pejman Ghanouni, MD, PhD, from Stanford University Medical Center and Suzanne LeBlang, MD, Chief Medical Officer of the Focused Ultrasound Foundation.  For the full link to article.

The article emphasizes that despite the high prevalence of fibroids, exceeding 80% among black women and nearly 70% of white women, there are few randomized trials to guide treatment decisions. While concern has been raised regarding overuse of hysterectomies — which account for nearly three quarters of all fibroid procedures – the article discusses several alternatives for women who want to retain their uterus and do not want to undergo the potential complications and recovery time associated with surgery. Link to the full article.