Eric Dolen, MD, Ohio Health adds, “MRgFUS is a valid treatment option for patients with symptomatic uterine fibroids. This change in labeling acknowledges this treatment option to be suitable not only for women who are family complete, but also for women who still plan on conceiving".

In addition to the change of labeling, the FDA also approved INSIGHTEC’s next generation Exablate system which offers treating physicians a more advanced technology. This important milestone also means that more patients in North America can now benefit from MRgFUS treatments.


Ramya Singh, INSIGHTEC’s Vice President of Americas said: “The combination of INSIGHTEC’s next generation system and the expansion of our labeling, brings new benefits to treating physicians and women alike, as we can now serve a larger cohort of patients. We as a company stay committed to extending our technological solutions in order to treat additional gynecology and oncology indications".

Professor Alan H. Matsumoto, MD, Radiology Chairman at the University of Virginia and President of the Society of Interventional Radiology commented: "The new version of the Exablate system enables treating physicians greater control of and more flexibility in treating fibroids with a clearer 3D view of the on-going treatment. With this new technology, treatment time is reduced allowing for treatment of more fibroid tissue in a given time".

These announcements reflect continuous strategic, technical, and regulatory commitments in an effort to continuously expand the patient population that is eligible for the treatment.

INSIGHTEC’s treatment platform was approved by the United States FDA for the treatment of the entire symptomatic fibroid tissue in 2009. This is the second labeling adjustment approved by the FDA since then.

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