The FDA has granted 510(k) marketing clearance to EDAP for its newly designed, high-end Sonolith I-Sys robotized device. Sonolith I-Sys has been developed to provide a highly effective product configuration to address what is one of the largest lithotripsy markets in the world. The integrated lithotripter utilizes EDAP’s unique and patented electroconductive technology, an advanced shockwave approach differentiated by its superior ability to successfully disintegrate urinary stones in association with combined x-ray or ultrasound systems.