inquisitive geek with fibroid tumors ™ blog

Received an email message from a visitor who wanted to pass along this information about the additional ExAblate 2000 approvals by the FDA. Thanks for the update!

From the email message:

The FDA approved new software that allows the ExAblate 2000 incisionless surgery procedure to be performed more efficiently by permitting more sonications during the same treatment window. This means that women with fibroids can be treated faster and women with larger fibroids may now be eligible for the outpatient procedure. The greater the area of the fibroid that a physician can treat, the greater the symptom relief. The agency is also allowing the system to be used with a more powerful open MRI machine, which means the physicians will have an even more precise view inside the woman’s body.

You can click the links to view the full press releases on Insightec’s web site but I included excerpts…

FDA Approves New Version of InSightec’s ExAblate(R) 2000 That Speeds up Treatment Time; More Women now Eligible for the Only Incisionless Treatment Option for Symptomatic Uterine Fibroids

HAIFA, Israel, March 1, 2007 – InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved software that significantly speeds up the treatment time of the company’s ExAblate 2000 Magnetic Resonance guided Focused Ultrasound (MRgFUS) system, while ensuring the system’s high level of safety and efficacy. Separately, the FDA also approved the ExAblate 2000 to be used with a 3.0 Tesla MRI scanner, in addition to the 1.5 Tesla…

FDA Approves use of InSightec’s ExAblate(R) 2000 With GE Healthcare’s 3 Tesla Magnetic Resonance Imaging System; Non-invasive Magnetic Resonance-guided Focused Ultrasound Uterine Fibroid Treatment Now Compatible With Both 1.5 Tesla and 3 Tesla Systems

HAIFA, Israel, March 1, 2007 – InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved use of the company’s ExAblate 2000 incisionless surgery system for uterine fibroids with GE Healthcare’s 3 Tesla Magnetic Resonance Imaging systems, based on studies conducted at University of California at San Diego (UCSD), Weill Cornell Medical Center and KNI Imaging. ExAblate 2000, which combines Magnetic Resonance Imaging with focused ultrasound waves (MRgFUS) to non-invasively destroy tumors, was previously approved for use with the 1.5 Tesla magnet in 2004…

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