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FDA APPROVES EXPANDED LABEL FOR INSIGHTEC’S ULTRASOUND UTERINE FIBROID DEVICE

8
März

Israeli devicemaker INSIGHTEC has adapted the label for its ultrasound technology designed to treat uterine fibroids, the ExAblate device, in order for it to be available to women who want to keep their uterus intact while still having the option to get pregnant.

 

The FDA has now signed off on this label adjustment, which will allow the company to continue moving forward with funding for R&D. The expanded approval is based on clinical data from 118 pregnancies that occurred after women were treated with the device.

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