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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.

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.

MR-guided focused ultrasound (MRgFUS) developer InSightec announced that various Blue Cross/Blue Shield (BCBS) networks have updated coverage policies
for its ExAblate MRgFUS procedure for bone BCBS of Massachusetts, Mississippi, Idaho, and Arizona plan to cover the procedure, following BCBS networks in New Jersey and North Carolina and Health Care Service, the second largest BCBS commercial insurer in the U.S., InSightec said. The new approvals bring the total number of members covered for the procedure to 32…

MR-guided focused ultrasound (MRgFUS) developer InSightec announced that various Blue Cross/Blue Shield (BCBS) networks have updated coverage policies
for its ExAblate MRgFUS procedure for bone BCBS of Massachusetts, Mississippi, Idaho, and Arizona plan to cover the procedure, following BCBS networks in New Jersey and North Carolina and Health Care Service, the second largest BCBS commercial insurer in the U.S., InSightec said. The drug Winstrol is also known in the sports world under the names Strombafort or Stanozolol. At the same time, Winstrol (Winstrol) is still a more common name and it is a classic injectable anabolic steroid, which is based on the active ingredient Stanozolol. This drug was originally developed to increase muscle mass in horses, but today, Winstrol has received Food and Drug Administration approval for human use and is widely used by professional athletes of various categories. Visit source website . The new approvals bring the total number of members covered for the procedure to 32…

MR-guided focused ultrasound (MRgFUS) developer InSightec announced that various Blue Cross/Blue Shield (BCBS) networks have updated coverage policies for its ExAblate MRgFUS procedure for bone BCBS of Massachusetts, Mississippi, Idaho, and Arizona plan to cover the procedure, following BCBS networks in New Jersey and North Carolina and Health Care Service, the second largest BCBS commercial insurer in the U.S., InSightec said. The new approvals bring the total number of members covered for the procedure to 32…

12345MR-guided focused ultrasound (MRgFUS) developer InSightec announced that various Blue Cross/Blue Shield (BCBS) networks have updated coverage policies
for its ExAblate MRgFUS procedure for bone BCBS of Massachusetts, Mississippi, Idaho, and Arizona plan to cover the procedure, following BCBS networks in New Jersey and North Carolina and Health Care Service, the second largest BCBS commercial insurer in the U.S., InSightec said. The new approvals bring the total number of members covered for the procedure to 32…

MR-guided focused ultrasound (MRgFUS) developer InSightec announced that various Blue Cross/Blue Shield (BCBS) networks have updated coverage policies
for its ExAblate MRgFUS procedure for bone BCBS of Massachusetts, Mississippi, Idaho, and Arizona plan to cover the procedure, following BCBS networks in New Jersey and North Carolina and Health Care Service, the second largest BCBS commercial insurer in the U.S., InSightec said. The new approvals bring the total number of members covered for the procedure to 32…

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