FDA Approves Label Change For Non-Invasive Fibroid Treatment

InSightec Ltd. announced that the U.S. Food and Drug Administration (FDA) approved a label change for the company’s ExAblate(R) 2000 MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with non-hysteroscopically resectable uterine fibroids. Under the new labeling, the agency allows physicians to treat up to 100% of the fibroid compared to its previous restriction to only treat up to half the fibroid tissue.

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Filed under: MRI / PET / Ultrasound on April 10th, 2009