• HIFU (Charlotte, North Carolina), a development-stage company, said Health Canada has granted the company a Class III medical device approval for the use of the Sonablate 500 in Canada for the treatment of prostate disease with high-intensity focused ultrasound (HIFU). The Sonablate 500, manufactured by Focus Surgery (Indianapolis), is a non-invasive device that uses HIFU to destroy tissue within the prostate without affecting surrounding tissue. In approved countries, HIFU with the Sonablate 500 has been successful as both a primary treatment for prostate disease and as a salvage treatment when radiation or surgery has failed, the company said.
• Syneron Medical (Yokneam, Israel) reported that the FDA has granted 510(k) clearance to the company’s VelaSmooth device, powered by elos (electro-optical synergy) technology, for the temporary reduction in the appearance of cellulite. The VelaSmooth also received clearance for the relief of minor muscle aches, pain and spasm and the temporary improvement of local blood circulation. The clearance of the VelaSmooth offers a new non-surgical, no downtime alternative for patients wishing to treat the appearance of cellulite, the company said. In addition to the 510(k) clearance, the FDA created a new product code for the VelaSmooth.