After a rather convoluted trip along the regulatory pathway, Edap TMS SA (Lyon, France) received 510(k) clearance from the FDA to market the Ablatherm integrated imaging high-intensity focused ultrasound (HIFU) in the U.S. for the ablation of prostate tissue. The company said the treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects.