Posted on October 15, 2015 by Sitemaster
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 »
Posted on October 13, 2015 by Sitemaster
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 »
Posted on October 3, 2014 by Sitemaster
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 »
Posted on August 11, 2014 by Sitemaster
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 »
Posted on July 31, 2014 by Sitemaster
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 »
Posted on May 22, 2014 by Sitemaster
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 »