Updated Sonablate High Intensity Focused Ultrasound receives 510(k) approval in US for prostate cancer- SonaCare Medical
SonaCare Medical reports receipt of 510(k) regulatory clearance to market its latest version of Sonablate in the United States. Sonablate was the first HIFU device to receive regulatory authorization from the Food and Drug Administration (FDA) for the focused ablation of prostate tissue.
This improved version of Sonablate technology includes new and updated features such as Tissue Change Monitoring, a tool that quantifies RF signals for changes in tissue composition following energy delivery; altered delivery sequences that, in combination with a new and more automated planning system, reduces overall procedure time by as much as 40%.
Comment: Sonablate received FDA clearance on October 09, 2015.
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