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Rad Oncology Homepage

Canon adds radiation oncology functioning to Aquilion CTs Can be shared between radiology and radiation oncology departments

Philips and MIM Software collab to streamline radiotherapy treatment planning Integrate portfolios of CT, MR and software solutions

ZAP Surgical launches radiosurgery platform for treating brain tumors Lowers cost of SRS with self-shielding technology

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Mevion to install PT system at Mercy Hospital St. Louis Equipped with HYPERSCAN technology

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Proton therapy pioneer James M. Slater dies at 89 Oversaw creation of the world's first proton treatment center

UK and US researchers develop AI models for evaluating emotional burden of cancer More clearly assesses reduction in quality of life

Courtesy of InSightec

InSightec’s ExAblate can spare uterus during fibroid treatment: FDA

by Lauren Dubinsky , Senior Reporter
InSightec announced on Wednesday that the FDA has approved the relabeling of the ExAblate system to treat women with symptomatic uterine fibroids who want to spare their uterus and maintain fertility. ExAblate can now be used for both women who are “family complete” and those who still want to conceive.

ExAblate combines focused ultrasound and MR technology to non-invasively treat uterine fibroids. High intensity focused ultrasound (HIFU) waves are used to heat and destroy the fibroid, and the MRI is used for treatment planning, real-time thermal monitoring during treatment and post-procedural assessment.

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The relabeling was approved based on a study that involved 118 patients who conceived after ExAblate treatments.

“This is a major breakthrough in the treatment of symptomatic uterine fibroids,” Dr. Haywood Brown, chairman of obstetrics and gynecology at Duke University School of Medicine, said in a statement. “Gynecologists can now offer patients a treatment that is not only noninvasive and uterus sparing, but with the new labeling, this treatment is also an option for women who are not family complete.”

The FDA also approved the next generation of the ExAblate system. The new version provides physicians with greater control of and more flexibility in treating uterine fibroids with a clearer 3-D view of the treatment as it’s happening.

“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,” Ramya Singh, vice president of Americas at InSightec, said in a statement.

Thousands of patients have been treated with ExAblate around the world. More than 70 peer reviewed papers have demonstrated that the procedure is safe and effective in treating uterine fibroids, with up to three year follow-up, according to InSightec.

ExAblate was first approved by the FDA to treat symptomatic fibroid tissue in 2009 and this has been the second labeling adjustment since then.

Rad Oncology Homepage


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