InSightech’s Noninvasive Ultrasound Device Receives FDA Signoff for Expanded Label

Israel-based medical devices manufacturer, InSightec, has received the U.S. FDA’s stamp of approval for its new ultrasound technology. The technology is indicated for the treatment of fibroids in women. The approval comes at a time when InSightec is trying to command a more dominant position in the U.S. medical devices market by raking in more revenue. The company has also been looking for greater funding avenues in a bid to support its current R&D activities.

The device, called ExAblate, now also carries an expanded label stating that the device is approved for use in women suffering from symptomatic uterine fibroids but who wish to keep their uterus intact so that they do not lose the option of becoming pregnant in the future. According to a statement by InSightec, the approval for the device by FDA was based on clinical data taken from 118 women who became pregnant after being treated with the ultrasound-technology-based device.

The new label for ExAblate is a well-timed achievement for the company, CEO Kobi Vortman stated in an official release. The company regards the new expanded label as a ‘major milestone’, the company’s CEO further stated in its statement. Currently, the company is in the process of running clinical trials to establish the efficacy of the device in treating multiple conditions and diseases. The functioning of the device is unique in that it combines two techniques—ultrasound ablation and magnetic resonance imaging—to remove problematic tissue via a noninvasive procedure. The company states that its device is capable of treating not just uterine fibroids, but also neuropathic pain and Parkinson’s.

The company currently manufactures products for sale in the European Union region and the device is used for a variety of indications. ExAblate already carries a signoff from the FDA for treating uterine fibroids as well as pain management in bone metastases in cases where radiation is not a feasible option.

InSightec is a company that’s already backed by GE, but will now set out to seek more funds so it can conduct more intensive R&D. The company says that it has already pumped in over US$200 mn into R&D initiatives.


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