Focus Surgery Inc., has received two regulatory approvals for its Sonablate 500 System, a system that performs prostrate imaging and treatment using ultrasound
Using FSI's patented ultrasound transducer technology, the SB-500 performs diagnostic level imaging of the prostate and performs minimally invasive image-guided treatment of both benign and cancerous prostate tissue using high intensity focused ultrasound (HIFU).
The SB-500 system received CE mark from UL International (UK) Ltd, a subsidiary of Underwriters Laboratory Inc. Under this authorized body, Focus Surgery received EC Certification.
In addition, Japan's Ministry of Health and Welfare (MHW) of Japan has also approved the SB-500 system for its clinical use for the treatment of image-guided therapy of benign prostatic hyperplasia (BPH). Based on this approval, Takai Hospital Supply Ltd. (THS) of Tokyo has begun marketing the SB-500 in Japan.
Narendra T. Sanghvi, president and chief executive officer of Focus Surgery, said: "These two regulatory bodies' approvals and certifications verifies our dedication to provide very high quality, state-of-the-art, minimally invasive treatment devices for the management of prostate diseases.
Based on the two approvals, Focus Surgery will now concentrate its efforts in marketing of the SB-500 in Asia and European countries working closely with potential distributors and partners.