InSightec ExAblate 2000 Approved For Uterine Fibroids; 3-Year Study Required
This article was originally published in The Gray Sheet
Executive Summary
FDA approval conditions for InSightec's ExAblate 2000 uterine fibroid ultrasound treatment respond to advisory panel concerns about short-term safety and efficacy data in the original PMA submission
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For InSightec, CMS Holds Ticket To Treating Fibroids In Younger Women
The lack of third-party reimbursement has hindered sales of InSightec's ExAblate 2000 uterine fibroid treatment, but the firm is hopeful that recent recommendations from CMS' advisory panel for hospital outpatient payments will help the unique treatment gain traction