FDA Approves Next Generation of INSIGHTEC Device


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The company earned FDA approval to treat uterine fibroids in 2004, but the recent ruling will enable physicians to utilize a more advanced version of the technology. 

INSIGHTEC’s announcement also notes an expanded labeling for its product, as patients no longer need to be family complete to be considered for the treatment. This change allows younger women who plan to conceive in the future to take advantage of this uterus-sparing procedure.

“The combination of INSIGHTEC’s next generation system and the expansion of our labeling, brings new benefits to treating physicians and women alike, as we can now serve a larger cohort of patients,” says Ramya Singh, the company’s Vice President of the Americas.

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