Topic: Japanese Tech
Israeli non-invasive treatment for uterine fibroids recommended for FDA approval
Israel21c.org July 25, 2004
... FDA panel's recommendation for the approval of a new Israeli-designed system for non-invasive treatment of uterine fibroids....The FDA's Obstetrics and Gynecology Devices Panel recently recommended the ExAblate 2000 System, manufactured by InSightec Ltd.
...The ExAblate system is intended to provide a non-invasive alternative to current treatments for symptomatic uterine fibroids, which include hysterectomy, myomectomy, uterine artery embolization, and drug therapy. The system uses focused ultrasound together with MR imaging to pinpoint tumors and effectively destroy them, without incisions, without anesthesia, and without the need for hospitalization.
...The device received the European CE mark in 2002 and is currently commercially available in Israel, Europe, and Japan.
The recent FDA panel recommendation was based on the results of a multicenter, controlled clinical study that was performed at centers in the United States, Europe, and Israel, including Brigham and Women's Hospital, the Mayo Clinic, and Johns Hopkins Hospital in the US, St. Mary's Hospital in London, Charite Hospital in Berlin, and Sheba Medical Center and Hadassah Hospital in Israel.
Posted by trek/taro
at 3:20 AM KDT
Updated: Monday, July 26, 2004 3:23 AM KDT
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Updated: Monday, July 26, 2004 3:23 AM KDT
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