FDA approves Sonablate 450 High Intensity Focused Ultrasound for prostate cancer- SonaCare Medical

SonaCare Medical received de novo clearance from the FDA to market the Sonablate 450 high intensity focused ultrasound in the US for the ablation of prostate tissue. It is the first high intensity focused ultrasound (HITU) device to receive FDA regulatory authorisation for prostate tissue ablation. SonaCare Medical expects to begin US distribution this October.

Sonablate is the Company’s second medical device to receive FDA regulatory authorisation, complementing the 510(k) cleared Sonatherm laparoscopic HITU ablation device. Other companies developing ablation systems for prostate cancer include EDAP TMS with the Focal One HIFU device, currently CE approved in the EU, Visualase with its MRI guided laser ablation system, which is in Phase II trials in the US, and Elekta's Synergy S Intensity Modulated RT which is approved in the EU and US but which uses image guided radiation beams, so is larger and more expensive to operate.