Monthly Archives: October 2014

HIFU FDA Application Stalled For Now

FDA Panel Doesn’t Recommend Device To Help Treat Recurrent Prostate Cancer. Medscape (10/3) reports and FDA advisory committee voted Oct. 1 “not to recommend approval, at least for now, of a high-intensity focused ultrasound (HIFU) device to treat some patients with recurrent prostate cancer.” The piece notes that the members of the Gastroenterology and Urology Devices Panel of the FDA’s Medical Devices Advisory Committee “encouraged the device manufacturer to continue to conduct research” but to return “when the ongoing pivotal trial at 20 sites” in the US and Canada is completed, “not halfway through.” SonaCare Medical Devices of Charlotte, NC, is seeking FDA approval of its Sonablate 450, “a computer-controlled device with a probe that clinicians can use to deliver HIFU energy through thermal ablation [...]

2017-12-13T13:37:56+00:00 October 4th, 2014|