New uterine fibroid treatment wins thumbs-up from FDA panel

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Yet more news on focused ultrasound...same old same old as yesterday...

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New uterine fibroid treatment wins thumbs-up from FDA panel

By Delporte

Medical Device Daily Washington Editor

GAITHERSBURG, land - Women in the United States suffering from

uterine fibroids are a step closer to having access to a new treatment

option.

With a vote of 8-5, the Obstetrics and Gynecology Panel of the FDA's

Center for Devices and Radiological Health recommended The ExAblate

2000 for market approval, with post-approval conditions. The ExAblate

2000 is manufactured by InSightec (Haifa, Israel/Dallas, Texas), a

privately held company owned by Elbit Medical Imaging (Tel-Aviv,

Israel) and GE Medical Systems (Waukesha, Wisconsin).

The device is the first magnetic resonance-guided focused ultrasound

surgery system to be reviewed by the panel and recommended for FDA

approval. The procedure already is approved in Europe and Israel.

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