Negative assessment for InSightec
This article was originally published in The Gray Sheet
Executive Summary
BlueCross BlueShield's Technology Evaluation Center says there is insufficient evidence to conclude that the firm's ExAblate 2000 MR-guided, focused ultrasound system improves net health outcomes of patients with symptomatic uterine fibroids. When the device received PMA approval in October 2004, the firm was required to collect postmarket data for three years (1"The Gray Sheet" Oct. 25, 2004, p. 20)...