Shares of EDAP TMS SA rocketed 57% in very active morning trade Friday, to pace the Nasdaq's gainers, after the France-based therapeutic ultrasound company said it received clearance from the U.S. Food and Drug Administration to market its Focal One device for the removal of prostate tissue. Volume ballooned to 13.6 million shares, compared with the full-day average of about 35,500 shares over the past 30 days. EDAP said its Focus One device is the first apparatus specifically designed for the prostate, and its use can lessen the damage to healthy tissue, minimize the side effects of incontinence and impotence. "Focal One's real-time imaging and 3D robotic features allow for greater precision, leading to improved targeting and treatment planning, and we are excited to be able to expand access to Focal One to the most important healthcare market in the world," said EDAP Chief Executive Marc Oczachowski. The stock has now climbed 14% over the past 12 months, while the SPDR Health Care Select Sector ETF has advanced 10% and the S&P 500 has rallied 14%.