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InSightec Granted CFDA Approval for Fibroid Treatment Device

Jul. 29, 2013

Israel-based InSightec Ltd, a leader in MR- guided Focused Ultrasound Therapy, announced on July 29, 2013 that its ExAblate system received approval of the Chinese Food and Drug Administration (CFDA) for non-invasive treatment of uterine fibroids. Uterine fibroids are benign tumors that grow in the uterus of 20-50% of women of childbearing age. ExAblate combines focused high-intensity ultrasound waves and continuous MRI guidance and monitoring. The focused ultrasound energy is used to ablate or destroy the fibroids while the MRI images are used to plan and guide the therapy and monitor treatment outcome. ExAblate is an incisionless procedure, requires no hospitalization, has a high safety profile with low risk of infection and complications and rapid recovery.