The U.S. Food & Drug Administration has now posted, on its web site, the approval letter issued to SonaCare Medical with reference to the approval to market the company’s Sonablate® 450 technology. … READ MORE …
Filed under: Treatment | Tagged: approval, FDA, HIFU, process, regulatory, Sonablate | 40 Comments »
According to a media release issued by SonaCare Medical early this morning, the company has received approval from the U.S. Food and Drug Administration (FDA) to market its Sonablate® 450 technology in the U.S.A. for prostate tissue ablation. … READ MORE …
Filed under: Management, Treatment | Tagged: focused, high-intensity, Sonablate, SonaCare, Treatment, ultrasound | 9 Comments »
According to a report posted yesterday on the Medscape web site, a Food and Drug Administration (FDA) advisory committee “voted October 1 not to recommend approval, at least for now” of a SonoCare Medical’s Sonablate high-intensity focused ultrasound (HIFU) device to treat patients with radio-recurrent … READ MORE …
Filed under: Management, Treatment | Tagged: focused, HIFU, high-intensity, Sonablate, SonoCare, ultrasound | 11 Comments »
Over the weekend, one of our regular commentators brought to our attention a newly published, retrospective analysis of data on the risks and benefits of treatment of localized prostate cancer with three successive generations of high-intensity focused ultrasound (HIFU) equipment from the company now known as Sonocare Medical. … READ MORE …
Filed under: Diagnosis, Management, Risk, Treatment | Tagged: focused, HIFU, high-intensity, Japan, Sonablate, ultrasound | 10 Comments »
In an entirely unsurprising result yesterday, an advisory committee to the U.S. Food and Drug Administration (FDA) voted very clearly against the approval of EDAP TMS’s Ablatherm technology for treatment of low-risk, localized prostate cancer using high-intensity focused ultrasound (HIFU). … READ MORE …
Filed under: Management, Treatment | Tagged: Ablatherm, FDA, focused, HIFU, high-intensity, Sonablate, ultrasound | 29 Comments »
According to a media release issued earlier today by EDAP TMS, the U.S. Food and Drug Administration (FDA) has scheduled a meeting on July 30, 2014, to review the Pre-Market Approval (PMA) application for EDAP’s Ablatherm-HIFU device for the treatment of localized prostate cancer. … READ MORE …
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: Ablatherm, focused, HIFU, high-intensity, Sonablate, SonoCare, ultarsound | 8 Comments »
