Top Story, Devices & Diagnostics

FDA approves expanded label for InSightec’s ultrasound uterine fibroid device

The ExAblate device's label, an ultrasound technology designed to treat uterine fibroids, has been adapted in order for it to be available to women who want to keep their uterus intact while still having the option to get pregnant.

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.

“This is a major milestone for the company. Over the years, the FDA has changed InSightec’s labeling for its uterine fibroids treatment, as more and more clinical data became available,” Dr. Kobi Vortman, CEO and Founder of InSightec said in a statement. “We view this change of labeling as a significant one, because it makes MRgFUS treatment for uterine fibroids accessible to many more women in the US, including women who desire fertility-sparing options for their symptomatic uterine fibroids. InSightec will continue to invest in developing our technology, in order to treat a wider range of clinical indications.”

The GE-backed company is currently bringing in new funds to support its R&D pursuits, which included a $59 million Series D round led by major investors in the U.S. and Asia last December. The company has already spent nearly $200 million on R&D. Additional funding could make a big difference to broaden ExAblate’s reach.

Photo: Flickr user Parker Knight

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